Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
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 medical device with a functional defect that could prevent proper assembly and use. No injuries or illnesses are reported, but the risk of harm exists if the device is used in an improperly assembled state, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM. The recall affects specific lots distributed in the United States, 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 were no longer in the installed location. These components are designed to have an interference fit, and their displacement could prevent the product from being properly assembled with the mating screw and targeting jig.
Healthcare providers and facilities should identify any affected units by checking the item number 814411320 and the specific lot numbers and expiration dates listed in the recall notice. Affected devices should be removed from use and returned to Zimmer Biomet for evaluation.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 125 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. 814411320
- 701830 (06/03/2027) UDI (01)00887868038464 (17)270603 (10)701830
- 893480 (06/12/2027) UDI (01) 00887868038464 (17)270612 (10)893480
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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