Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially 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 is classified as FDA Class II, and the defect poses a risk of harm by preventing proper assembly of a medical device, although no injuries or illnesses have been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM. The affected products were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
The recall was initiated because it was detected during the rework process for an April 17, 2017, 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 assembly with the mating screw and targeting jig.
Healthcare providers and facilities should identify any affected units by checking for Item No. 814611460 and the specific lot numbers and expiration dates listed in the recall notice. Affected units should be removed from use and returned to Zimmer Biomet for evaluation.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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. 814611460
- 788580 (07/17/2027) UDI (01)00887868039867 (17)270717 (10)788580
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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