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

Recall Z-1127-2016 — Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty

U.S. FDA — Device Enforcement · United States · 2016-01-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1127-2016
Date of alert
2016-01-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Manufacturing B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
62051735
Reported risk: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
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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