Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper 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 structural defect in a high-risk medical device (orthopedic implant) that could prevent proper assembly. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM. The affected units were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
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 their installed location. This defect could prevent the product assembly with the mating screw and targeting jig.
Healthcare providers and facilities should check their inventory for the specific item number 814511320 and the listed lot numbers (480090, 893410, 942070) to identify affected units. Patients who have already had this specific device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM
- 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 (3)
- Item No. 814511320
- 893410 (06/12/2027) UDI (01)00887868039140 (17)270612 (10)893410
- 942070 (07/17/2027) UDI (01)00887868039140 (17)270717 (10)942070
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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