Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 31 Affixus Hip Fracture Nails because sterile packaging was found open during 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 is classified as FDA Class II and involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 31 units of the Affixus Hip Fracture Nail Left 125 13 mm x 340 mm (Item Number 814413340). The recall is due to complaints indicating that the sterile packaging was already open when the product was opened in surgery.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The specific lot numbers involved are 369380 and 436290.
This recall is classified as Class II by the FDA. Healthcare providers should check their inventory for these specific item numbers and lot numbers and stop using the affected devices.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 31
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: 369380 436290
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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