Zimmer Natural Nail cephalomedullary device angle mismatch recall
Zimmer GmbH is recalling its Cephalomedullary Short Nail due to potential mix-up between 125 and 130 degree CCD angle versions. Eight units with Lot 3020731 are affected and distributed to CA, GA, KY, MD, and internationally.
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: This FDA Class II recall involves a potential mix-up of orthopedic implant angles. No injuries or illnesses have been reported. The hazard is theoretical rather than demonstrated, supporting a High severity rating per the rubric's criteria for risk-of-harm products with no reported injuries.
Plain-English summary
Zimmer GmbH is recalling certain units of the Zimmer Natural Nail (ZNN) Cephalomedullary Short Nail (Item Number 47-2493-211-11) due to a potential commingle between 125-degree and 130-degree CCD angle versions. The recalled product is an 11.5 mm X 21.5 cm orthopedic implant intended for temporary fracture fixation and bone stabilization.
The potential mix-up between different CCD angle versions could result in incorrect angle implantation, which may affect fracture fixation stability. No illnesses or injuries have been reported at this time.
Eight units were affected with Lot Number 3020731 (UDI: (01) 0088902498880 (17) 300131 (10) 3020731). Distribution includes California, Georgia, Kentucky, and Maryland in the United States, plus Australia, Brazil, Canada, and the Netherlands internationally.
Healthcare providers who received this product should cease use and contact Zimmer GmbH for instructions on product return or replacement.
The recalled product
- Product
- Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
- Manufacturer
- Zimmer GmbH
- Hazard
- device-mix-up
- component-mismatch
- implant-failure-risk
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 Number: 3020731 UDI: (01) 0088902498880 (17) 300131 (10) 3020731
Distribution
Distributed in 4 states:
- CA
- GA
- KY
- MD
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