Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 10 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves compromised sterile packaging, which is a significant quality issue but the source does not report specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 10 units of the Affixus Hip Fracture Nail Left 130 15 mm x 360 mm (Item Number 814615360, Lot Number 436650). The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery. The product is intended for the fixation of fractures.
The affected units were distributed nationwide in the United States and to foreign countries including Chile and the Netherlands. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
Healthcare providers and facilities should stop using the affected lots and contact Zimmer Biomet for instructions on return or replacement. Patients who have had this specific device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 10
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: 436650
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 · sterile packaging compromise
See all →- SevereCenturion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns
FDA (Devices) · 2019-08-14
- HighFDA Recalls 850 Units of Covidien Force TriVerse Electrosurgical Devices
FDA (Devices) · 2019-03-27
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
FDA (Devices) · 2018-10-24
- ModerateZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
FDA (Devices) · 2018-10-24
- ModerateZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
FDA (Devices) · 2018-10-24