Recall Z-1029-2014 — 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEMENTED FEM STEM VER
U.S. FDA — Device Enforcement · United States · 2013-10-11 · Class II
⚙AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Reported risk: 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 packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.