FDAFDA · Food and drugs·Recall number Z-0434-2018
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Published February 7, 2018 · Recall initiated: August 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- US nationwide distribution. Also Portugal and the Netherlands.
- Lot
- Item No. 814611340; Lot No. (Exp. Date) UDI: 535240 (05/24/2027) UDI (01)00887868039805 (17)270524 (10)535240
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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