Zimmer Biomet Recalls ACE Trochanteric Nail System After Failed Performance Review
Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.
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. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Zimmer Biomet, Inc. is conducting a recall of the ACE Trochanteric Nail (ATN) System. The recall involves 3,454 units of the device, which were distributed nationwide in the United States.
The recall was initiated after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system. The source text does not specify reported injuries, illnesses, or fatalities associated with this recall.
Consumers and healthcare providers should verify if they possess the affected product codes and contact Zimmer Biomet for further instructions on the recall.
The recalled product
- Product
- ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H T
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3,454
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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