Reported Feb 7, 2018 · Terminated
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
- Lot codes and dates
- Item No. 814611280; Lot No. (Exp
- Date) UDI459270 (05/18/2027) UDI (01)00887868039775 (17)270518 (10)459270; 858780 (06/16/2027) UDI (01)00887868039775 (17)270616 (10)858780; 972840 (06/15/2027) UDI (01)00887868039775 (17)270615 (10)972840
- Amount recalled
- 638 units
This recall covers 65 products
The agency filed one notice per product. You are reading one of them; the other 64 are below.
52 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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