Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect could prevent proper assembly, posing a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM. The recall was initiated after it was detected during a rework process for a previous field action that the set screw and sleeve assembly, which are designed to have an interference fit, were no longer in the installed location.
This defect could prevent the product from being properly assembled with the mating screw and targeting jig. The affected devices were distributed nationwide in the United States, as well as in Portugal and the Netherlands. The specific lot number is 702050 with an expiration date of 06/12/2027.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or replace them. Patients who have already received the implant should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 638
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item No. 814309260
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 65 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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