Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1951-2016 — TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM - 00588604414 TM C

U.S. FDA — Device Enforcement · United States · 2016-04-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1951-2016
Date of alert: 2016-04-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Trabecular Metal Technology, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00588604310

Reported risk: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.

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