Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles that may fail to remain assembled during use.
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 mechanical failure of a medical device that poses a risk of harm, but the source text does not report any specific injuries or hospitalizations.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the Double Offset Rasp Handle, Left Hand Nonsterile (Item Number 82016757931, Lot Number 97009560). The recall was initiated after the firm received complaints that the handle failed to remain assembled to the rasp during use. The specific failure modes identified include the fracture of the leaf spring.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and consumers should stop using the recalled handles immediately. Users should contact Zimmer, Inc. for further instructions on how to return or dispose of the affected devices.
The recalled product
- Product
- Double Offset Rasp Handle, Left Hand Nonsterile
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 412
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)
- Item Number 82016757931 Lot Number 97009560
Distribution
Part of a larger recall action
This product is one of 16 recalled by Zimmer, 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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