Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk medical device where a breach in sterile packaging poses a significant risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 16 units of the Affixus Hip Fracture Nail Left 125 13 mm x 260 mm (Item Number 814413260). The product is intended for the fixation of fractures and was distributed nationwide in the United States and in Chile and the Netherlands.
The recall was initiated due to complaints indicating that the sterile packaging was already open when the product was opened in surgery. This condition raises concerns regarding the sterility of the implant.
Healthcare providers and facilities that have received these specific units should stop using them and contact Zimmer Biomet for instructions on return or replacement. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 16
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 (1)
- Lot Numbers: 679240
Distribution
Part of a larger recall action
This product is one of 48 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 48 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 · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
FDA (Devices) · 2018-02-07
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
FDA (Devices) · 2018-02-07
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue
FDA (Devices) · 2018-09-19
- SevereZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
FDA (Devices) · 2018-09-19