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

Recall Z-1092-2014 — 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacemen

U.S. FDA — Device Enforcement · United States · 2014-01-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1092-2014
Date of alert: 2014-01-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 62267250

Reported risk: This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification.

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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