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

Product 29 consists of all product under product code: LPHand same… — recall Z-1127-2016

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

As described by U.S. FDA — Device Enforcement: 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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
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
Notice type
recall
Brand
Zimmer Manufacturing B.V.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

Related

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.