Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 24 units of Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
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 the loss of sterile packaging creates a significant risk of harm (infection), 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 24 units of Affixus Hip Fracture Nail Right 125 13 mm x 260 mm (Item Number 814313260, Lot Number 343500). The product is intended for the fixation of fractures.
The recall was initiated due to complaints indicating that the sterile packaging was already open when the product was opened in surgery. This presents a risk of contamination or loss of sterility.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. Healthcare providers should stop using the affected units and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 24
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: 343500
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.
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