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DePuy Orthopaedics, Inc.

702 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of th recall (Z-1456-2024)DePuy Orthopaedics, Inc.2024-03-29
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760 recall (Z-1263-2023)DePuy Orthopaedics, Inc.2023-03-17
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 1517602 recall (Z-1264-2023)DePuy Orthopaedics, Inc.2023-03-17
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 1517602 recall (Z-1265-2023)DePuy Orthopaedics, Inc.2023-03-17
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 15176031 recall (Z-1266-2023)DePuy Orthopaedics, Inc.2023-03-17
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507 recall (Z-1267-2023)DePuy Orthopaedics, Inc.2023-03-17
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutt recall (Z-1169-2020)DePuy Orthopaedics, Inc.2020-02-13
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Impl recall (Z-1703-2018)DePuy Orthopaedics, Inc.2018-04-30
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Impl recall (Z-1704-2018)DePuy Orthopaedics, Inc.2018-04-30
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 106032 recall (Z-1219-2018)DePuy Orthopaedics, Inc.2018-03-20
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total sho recall (Z-1012-2018)DePuy Orthopaedics, Inc.2018-02-27
CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 recall (Z-0593-2018)DePuy Orthopaedics, Inc.2018-02-12
CORAIL HIGH OFFSET STEM Collarless SIZE 14 recall (Z-0594-2018)DePuy Orthopaedics, Inc.2018-02-12
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee recall (Z-0703-2017)DePuy Orthopaedics, Inc.2016-12-03
ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, the recall (Z-0650-2017)Depuy Orthopaedics Inc.2016-11-21
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizi recall (Z-0787-2016)DePuy Orthopaedics, Inc.2016-02-09
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400m recall (Z-0111-2016)DePuy Orthopaedics, Inc.2015-10-07
ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface recall (Z-2137-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface T recall (Z-2138-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface T recall (Z-2139-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articula recall (Z-2140-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface T recall (Z-2141-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surfac recall (Z-2142-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface recall (Z-2143-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps to recall (Z-2144-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface T recall (Z-2145-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snap recall (Z-2146-2015)DePuy Orthopaedics, Inc.2015-07-20
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis componen recall (Z-1672-2015)DePuy Orthopaedics, Inc.2015-05-26
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery. recall (Z-1673-2015)DePuy Orthopaedics, Inc.2015-05-26
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip i recall (Z-1357-2015)DePuy Orthopaedics, Inc.2015-03-31
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate ba recall (Z-1246-2015)DePuy Orthopaedics, Inc.2015-03-05
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacem recall (Z-0953-2015)DePuy Orthopaedics, Inc.2015-01-12
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useab recall (Z-0903-2015)DePuy Orthopaedics, Inc.2015-01-05
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re- recall (Z-0904-2015)DePuy Orthopaedics, Inc.2015-01-05
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable recall (Z-0905-2015)DePuy Orthopaedics, Inc.2015-01-05
I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator g recall (Z-0908-2015)DePuy Orthopaedics, Inc.2015-01-05
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace t recall (Z-0825-2015)DePuy Orthopaedics, Inc.2014-12-17
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap a recall (Z-0199-2015)DePuy Orthopaedics, Inc.2014-11-10
Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Char recall (Z-0061-2015)DePuy Orthopaedics, Inc.2014-10-09
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment devi recall (Z-0038-2015)DePuy Orthopaedics, Inc.2014-10-08
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Ins recall (Z-2082-2014)DePuy Orthopaedics, Inc.2014-07-21
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM recall (Z-2083-2014)DePuy Orthopaedics, Inc.2014-07-21
RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revisio recall (Z-2084-2014)DePuy Orthopaedics, Inc.2014-07-21
GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-St recall (Z-1437-2014)DePuy Orthopaedics, Inc.2014-04-09
REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left recall (Z-1203-2014)DePuy Orthopaedics, Inc.2014-03-13
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Rig recall (Z-1204-2014)DePuy Orthopaedics, Inc.2014-03-13
REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Lef recall (Z-1205-2014)DePuy Orthopaedics, Inc.2014-03-13
REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Righ recall (Z-1206-2014)DePuy Orthopaedics, Inc.2014-03-13
REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left recall (Z-1207-2014)DePuy Orthopaedics, Inc.2014-03-13
REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right recall (Z-1208-2014)DePuy Orthopaedics, Inc.2014-03-13
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during prima recall (Z-1077-2014)DePuy Orthopaedics, Inc.2014-02-24
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee I recall (Z-0412-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Ins recall (Z-0413-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Ins recall (Z-0414-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Kne recall (Z-0415-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee recall (Z-0416-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee recall (Z-0417-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instru recall (Z-0418-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrume recall (Z-0419-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrume recall (Z-0420-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Ins recall (Z-0421-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instr recall (Z-0422-2014)DePuy Orthopaedics, Inc.2013-11-27
SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instr recall (Z-0423-2014)DePuy Orthopaedics, Inc.2013-11-27
SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, recall (Z-0064-2014)DePuy Orthopaedics, Inc.2013-10-23
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the recall (Z-1820-2013)DePuy Orthopaedics, Inc.2013-07-31
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an recall (Z-1520-2013)DePuy Orthopaedics, Inc.2013-06-07
Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: recall (Z-1366-2013)DePuy Orthopaedics, Inc.2013-05-22
DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are de recall (Z-1331-2013)DePuy Orthopaedics, Inc.2013-05-16
ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip recall (Z-0972-2013)DePuy Orthopaedics, Inc.2013-03-20
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments recall (Z-0971-2013)DePuy Orthopaedics, Inc.2013-03-19
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS Sys recall (Z-0828-2013)DePuy Orthopaedics, Inc.2013-02-15
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS Sys recall (Z-0829-2013)DePuy Orthopaedics, Inc.2013-02-15
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS Sys recall (Z-0830-2013)DePuy Orthopaedics, Inc.2013-02-15
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS Sys recall (Z-0831-2013)DePuy Orthopaedics, Inc.2013-02-15
SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protect recall (Z-0573-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with prot recall (Z-0574-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with prote recall (Z-0575-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with prote recall (Z-0576-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with prote recall (Z-0577-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with prote recall (Z-0578-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with pr recall (Z-0579-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with pr recall (Z-0580-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with pr recall (Z-0581-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with prot recall (Z-0582-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with pr recall (Z-0583-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with prot recall (Z-0584-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with pr recall (Z-0585-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with pr recall (Z-0586-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with pr recall (Z-0587-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with pr recall (Z-0588-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with prot recall (Z-0589-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with pr recall (Z-0590-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with prot recall (Z-0591-2013)DePuy Orthopaedics, Inc.2012-12-20
SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with pr recall (Z-0592-2013)DePuy Orthopaedics, Inc.2012-12-20
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; th recall (Z-0569-2013)DePuy Orthopaedics, Inc.2012-12-19
S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch recall (Z-2414-2012)DePuy Orthopaedics, Inc.2012-09-20
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the imp recall (Z-2220-2012)DePuy Orthopaedics, Inc.2012-08-17
DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was recall (Z-2217-2012)DePuy Orthopaedics, Inc.2012-08-16
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer recall (Z-1906-2012)DePuy Orthopaedics, Inc.2012-06-29
ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer recall (Z-1907-2012)DePuy Orthopaedics, Inc.2012-06-29
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