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DePuy Orthopaedics, Inc.

702 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 6 hole, Sterile, REF 8141-31-106 recall (Z-1582-2011)Depuy Orthopaedics, Inc.2011-03-07
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 9 hole, Sterile, REF 8141-31-109 recall (Z-1583-2011)Depuy Orthopaedics, Inc.2011-03-07
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF 8141-31-11 recall (Z-1584-2011)Depuy Orthopaedics, Inc.2011-03-07
POLYAX FEMORAL PLATE - LEFT, 15 hole, Sterile, REF 8141-31-115, Depuy Orthopaedics, Inc., recall (Z-1585-2011)Depuy Orthopaedics, Inc.2011-03-07
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 18 hole, Sterile, REF 8141-31-11 recall (Z-1586-2011)Depuy Orthopaedics, Inc.2011-03-07
PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 9 hole, Sterile, REF 8141-30-10 recall (Z-1587-2011)Depuy Orthopaedics, Inc.2011-03-07
S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy In recall (Z-1388-2011)Depuy Orthopaedics, Inc.2011-02-22
S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy Interna recall (Z-1389-2011)Depuy Orthopaedics, Inc.2011-02-22
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46 recall (Z-0013-2011)Depuy Orthopaedics, Inc.2010-10-06
DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, sterile, DePuy International, Ltd, Lee recall (Z-203-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 44 mm, 999800744, sterile, DePuy International, Ltd, Lee recall (Z-2031-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, sterile, DePuy International, Ltd, Lee recall (Z-2032-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 48 mm, 999800748, sterile, DePuy International, Ltd, Lee recall (Z-2033-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 52 mm, 999800752, sterile, DePuy International, Ltd, Lee recall (Z-2035-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 54 mm, 999800754, sterile, DePuy International, Ltd, Lee recall (Z-2036-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 56 mm, 999800756, sterile, DePuy International, Ltd, Lee recall (Z-2037-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 57 mm, 999890157, sterile, DePuy International, Ltd, Lee recall (Z-2038-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 58 mm, 999800758, sterile, DePuy International, Ltd, Lee recall (Z-2039-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 66 mm, 999805966, sterile, DePuy International, Ltd, Lee recall (Z-2040-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 60 mm, 999800760, sterile, DePuy International, Ltd, Lee recall (Z-2041-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 62 mm, 999800762, sterile, DePuy International, Ltd, Lee recall (Z-2042-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 64 mm, 999805764, sterile, DePuy International, Ltd, Lee recall (Z-2043-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 68 mm, 999806168, sterile, DePuy International, Ltd, Lee recall (Z-2044-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 100 Acetabular Implant, 70 mm, 999806370, sterile, DePuy International, Ltd, Lee recall (Z-2045-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 44 mm, 999830744, sterile, DePuy International, Ltd, Lee recall (Z-2046-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 46 mm, 999830746, sterile, DePuy International, Ltd, Lee recall (Z-2047-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, sterile, DePuy International, Ltd, Lee recall (Z-2048-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 50 mm, 999830750, sterile, DePuy International, Ltd, Lee recall (Z-2049-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 52 mm, 999830752, sterile, DePuy International, Ltd, Lee recall (Z-2050-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 54 mm, 999830754, sterile, DePuy International, Ltd, Lee recall (Z-2051-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, sterile, DePuy International, Ltd, Lee recall (Z-2052-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd, Lee recall (Z-2053-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 60 mm, 999830760, sterile, DePuy International, Ltd, Lee recall (Z-2054-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, sterile, DePuy International, Ltd, Lee recall (Z-2055-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 64 mm, 999830764, sterile, DePuy International, Ltd, Lee recall (Z-2056-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 66 mm, 999830766, sterile, DePuy International, Ltd, Lee recall (Z-2057-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 68 mm, 999830768, sterile, DePuy International, Ltd, Lee recall (Z-2058-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy ASR 300 Acetabular Implant, 70 mm, 999830770, sterile, DePuy International, Ltd, Lee recall (Z-2059-2010)Depuy Orthopaedics, Inc.2010-07-17
DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L recall (Z-1686-2009)Depuy Orthopaedics, Inc.2009-08-21
DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; recall (Z-0981-2009)Depuy Orthopaedics, Inc.2009-02-11
DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF DNPAJI recall (Z-0982-2009)Depuy Orthopaedics, Inc.2009-02-11
DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left, Depuy, Warsaw, IN; REF DNPAL recall (Z-0983-2009)Depuy Orthopaedics, Inc.2009-02-11
DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Right, Depuy, Warsaw, IN; REF DNPA recall (Z-0984-2009)Depuy Orthopaedics, Inc.2009-02-11
Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 13073 recall (Z-0532-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 1307 recall (Z-0533-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 1307 recall (Z-0534-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130 recall (Z-0535-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 1307 recall (Z-0536-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 1307 recall (Z-0537-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 1307 recall (Z-0538-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 1307 recall (Z-0539-2009)Depuy Orthopaedics, Inc.2009-01-15
Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, recall (Z-1812-2008)Depuy Orthopaedics, Inc.2008-09-17
Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, steri recall (Z-0434-2008)Depuy Orthopaedics, Inc.2008-01-24
Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; R recall (Z-0435-2008)Depuy Orthopaedics, Inc.2008-01-24
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, recall (Z-0385-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, recall (Z-0386-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, recall (Z-0387-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, recall (Z-0388-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, recall (Z-0389-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, recall (Z-0390-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, recall (Z-0391-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, recall (Z-0392-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, recall (Z-0393-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, recall (Z-0394-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, recall (Z-0395-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti recall (Z-0396-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti recall (Z-0397-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 m recall (Z-0398-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, U recall (Z-0399-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI recall (Z-0400-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI recall (Z-0401-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, recall (Z-0402-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 recall (Z-0403-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47 recall (Z-0404-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51m recall (Z-0405-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51 recall (Z-0406-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55 recall (Z-0407-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Curved Tibial Insert (RP-CVD), 10mm, Size recall (Z-0408-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5mm recall (Z-0409-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, recall (Z-0410-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 m recall (Z-0411-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 15 mm, recall (Z-0412-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 m recall (Z-0413-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, recall (Z-0414-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 m recall (Z-0415-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, recall (Z-0416-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 m recall (Z-0417-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, recall (Z-0418-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4 recall (Z-0419-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, recall (Z-0420-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P recall (Z-0421-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P recall (Z-0422-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P recall (Z-0423-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P recall (Z-0424-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P recall (Z-0425-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P recall (Z-0426-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P recall (Z-0427-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile; Product Code/RE recall (Z-0428-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/RE recall (Z-0429-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile; Product Code/RE recall (Z-0430-2008)Depuy Orthopaedics, Inc.2007-12-06
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