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

Recall Z-1379-2013 — Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert

U.S. FDA — Device Enforcement · United States · 2013-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1379-2013
Date of alert: 2013-02-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Orthopedic Alliance LLC
Product category: device
Product type: Devices

Reported risk: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

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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