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Ortho Development Corporation

23 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty recall (Z-2253-2014)Ortho Development Corporation2014-08-17
Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resur recall (Z-2254-2014)Ortho Development Corporation2014-08-17
PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to s recall (Z-2255-2014)Ortho Development Corporation2014-08-17
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used i recall (Z-2256-2014)Ortho Development Corporation2014-08-17
Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE compone recall (Z-2257-2014)Ortho Development Corporation2014-08-17
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee Syste recall (Z-1610-2014)Ortho Development Corporation2014-05-13
U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup Syste recall (Z-0740-2012)Ortho Development Corporation2012-01-13
Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho De recall (Z-2602-2011)Ortho Development Corporation2011-06-20
Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho De recall (Z-2603-2011)Ortho Development Corporation2011-06-20
Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, recall (Z-1670-2011)Ortho Development Corporation2011-03-16
Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development, D recall (Z-1671-2011)Ortho Development Corporation2011-03-16
Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development, D recall (Z-1672-2011)Ortho Development Corporation2011-03-16
Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Developme recall (Z-1673-2011)Ortho Development Corporation2011-03-16
Distal Centralizer 10 mm recall (Z-0315-2011)Ortho Development Corporation2010-11-03
10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System. recall (Z-1228-2010)Ortho Development Corporation2010-04-05
5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The de recall (Z-1229-2010)Ortho Development Corporation2010-04-05
Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head. recall (Z-0086-2010)Ortho Development Corporation2009-10-28
Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Si recall (Z-1993-2009)Ortho Development Corporation2009-09-09
Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. recall (Z-0042-04)Ortho Development Corporation2003-10-15
Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System. recall (Z-0566-03)Ortho Development Corporation2003-02-25
Hip Prosthesis as a component of Primaloc Cementless/Collarless Hip System recall (Z-0567-03)Ortho Development Corporation2003-02-25
Hip Prosthesis as a component of Primaloc Cemented Hip System. recall (Z-0568-03)Ortho Development Corporation2003-02-25
Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in recall (Z-0569-03)Ortho Development Corporation2003-02-25

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Every clearance here is in the API, with alerts when new ones post.