Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 60 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
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 high-risk medical device where the breach of sterile packaging poses a risk of harm (infection), but the source text does not report any specific illnesses or injuries, 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 60 units of the Affixus Hip Fracture Nail - Left 125 11mm x 340mm (Item Number 814411340). The affected lots are 244280, 558120, and 558130. The product is intended for the fixation of fractures.
The recall was initiated due to complaints indicating that when the product was opened in surgery, the sterile packaging was already open. This issue compromises the sterility of the medical device.
The products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. Healthcare providers and facilities that have received these specific lots should stop using the product and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 60
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: 244280 558120 558130
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 →- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- HighIntracept Access Instruments sterile barrier breach risk
FDA (Devices) · 2026-07-15
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08