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

Recall Z-1523-2015 — Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

U.S. FDA — Device Enforcement · Switzerland · 2015-03-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1523-2015
Date of alert
2015-03-18
Country / jurisdiction
Switzerland
Risk level
Class II
Risk type
recall
Brand
Zimmer Gmbh
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
13870129
Reported risk: Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in 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.

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