Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced set screws and sleeves, 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 medical device with a functional defect that could prevent proper assembly, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM. The affected devices 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 from working correctly with the mating screw and targeting jig.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or dispose of the product. The specific lot numbers and expiration dates for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 125 DEG 9MM 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 (2)
- Item No. 814309320
- 737670 (06/14/2027) UDI (01)00887868038006 (17)270614 (10)737670
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.
See all 65 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · assembly defect
See all →- ModerateOctopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateCardiosave battery charging station left bay screw prevents full battery insertion
FDA (Devices) · 2026-03-25
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04