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 during rework, potentially preventing proper assembly.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no injuries are explicitly reported, the defect prevents proper assembly of a critical orthopedic implant, fitting the 'Severe' criteria for structural/functional defects in high-risk medical devices.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM (Item No. 814513280). The affected lots are 581960 (expiration date 05/31/2027) and 858740 (expiration date 06/26/2027). The products were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
The recall was initiated because, during the rework process for a field action conducted on April 17, 2017, it was detected that the set screw and sleeve assembly were no longer in their installed location. These components are designed to have an interference fit. Their displacement could prevent the product from being properly assembled with the mating screw and targeting jig.
This recall is classified as Class II by the FDA. No specific instructions for consumers are provided in the source text, as this is a medical device recall managed by the manufacturer and healthcare providers.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
- 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 (2)
- Item No. 814513280
- 858740 (06/26/2027) UDI (01)00887868039263 (17)270626 (10)858740
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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