Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp 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 the source text describes a mechanical failure of a medical device during use without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the Double Offset Rasp Handle, Left Hand Nonsterile. The recall was initiated after the firm received complaints that the handle failed to remain assembled to the rasp during use. The failure modes included the fracture of the leaf spring.
The affected product is identified by Item Number 82016757831 and Lot Numbers 97008287, 97900066, 97900084, 97900106, and 97900158. The products were distributed nationwide in the United States and internationally to Australia, France, Germany, Italy, Switzerland, and Canada.
Consumers and healthcare providers should stop using the affected handles and contact Zimmer, Inc. for instructions on how to return the product.
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 (5)
- Item Number 82016757831 Lot Number 97008287
- 97900066
- 97900084
- 97900106
- 97900158
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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