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 6 Degree COCR Femoral Heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 7,044,680 humeral intramedullary nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling specific lots of Modular Austin Moore and Moore Hip ProS hip implants because packaging operations at a Puerto Rico facility were not properly validated.
Zimmer is recalling 7,044,680 one-piece lag screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling Magna-Fx Cannulated Screw Fixation Systems because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling CPT Degree Taper and Femoral HD devices due to unvalidated packaging operations at a Puerto Rico facility.
Zimmer is recalling 7 million sterile orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling specific hip prosthesis models because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer, Inc. is recalling 7,044,680 self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer is recalling specific Free-Lock orthopedic devices because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 7,044,680 orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer is recalling Versys Heritage Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer, Inc. is recalling 7,044,680 units of Pressfit Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated.
Zimmer is recalling 7 million self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 12/14 femoral heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling CPT 12/14 COCR devices because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 7,044,680 units of bipolar liners and multipolar cups because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling specific orthopedic implants because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 7,044,680 Asia One-Piece Lag Screws because packaging operations at a Puerto Rico facility were not properly validated, potentially affecting sterile barrier integrity.
Zimmer is recalling 7,044,680 units of Herbert Bone Screws and Cannulated Bone Screws because packaging operations at a Puerto Rico facility were not properly validated.
Zimmer is recalling interlocking IM screws and tibial nails sterile packaged at a Puerto Rico facility because packaging operations were not properly validated.
Zimmer is recalling 7,044,680 compression screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling Trilogy Acet Shell and Bone Screw devices due to unvalidated packaging operations at its Puerto Rico facility.
Zimmer is recalling HGP II Acetabular Cup Bon due to unvalidated packaging operations at its Puerto Rico facility, despite passing seal integrity tests.
Zimmer is recalling Versa-FX II knee implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.