FDA (Devices) recall action 66500
The FDA (Devices) publishes a recall like this one as 44 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 44 pages.
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These p…
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zimmer is recalling M/DN R-F IM Nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling FEM HD ION hip implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 7,044,680 modular hip cup liners because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling specific sterile orthopedic screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling specific sterile orthopedic screws and nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 3.5 compression plates sterile packaged at its Puerto Rico facility because packaging operations were not properly validated, despite passing seal integrity tests.
Zimmer, Inc. is recalling ZIMTRON 6 DEG 22 Heads because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer is recalling Versys femoral stems because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling NEXGEN knee implant components because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling HGP II Acetabular Cup Mod units because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling specific knee implant components because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling Interlocking IM Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling NEXGEN Osteotomy Cortical Bone Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 6 Degree COCR Femoral Heads and 6 Degree Unipolar Femoral Heads because packaging operations at a Puerto Rico facility were not properly validated.
Zimmer is recalling ITST anti-rotation screws and femoral intramedullary nails due to unvalidated packaging operations at its Puerto Rico facility.
Zimmer is recalling specific bone screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling specific Versa-FX orthopedic implant lots because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling Modular Austin Moore Femoral Neck implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer, Inc. is recalling specific hip prosthesis models because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.