Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 nonsterile 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 involves a medical device with a mechanical failure that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the Double Offset Rasp Handle, Left Hand Nonsterile. The recall involves Item Number 82016757821, specifically Lot Numbers 97005188 and 97005789.
The firm initiated the recall after receiving complaints that the handle failed to remain assembled to the rasp during use. The source text identifies various failure modes, including the fracture of the leaf spring, as the cause of these issues.
The affected products were distributed worldwide, including nationwide distribution in the United States and in the countries of Australia, France, Germany, Italy, Switzerland, and Canada. Consumers and healthcare providers should stop using the affected units and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Double Offset Rasp Handle, Left Hand Nonsterile
- Manufacturer
- Zimmer, Inc.
- 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 (2)
- Item Number 82016757821 Lot Number 97005188
- 97005789
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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