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 is classified as FDA Class II and involves a mechanical failure of a medical device during use, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the Double Offset Rasp Handle, Left Hand Nonsterile. The recall is due to complaints that the handle failed to remain assembled to the rasp during use. The failure modes include fracture of the leaf spring.
The affected product is identified by Item Number 82016757830 and Lot Number 97009559. The units were distributed nationwide in the United States, including specific states such as AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA. The product was also distributed in Australia, France, Germany, Italy, Switzerland, and Canada.
Healthcare professionals should stop using the recalled handles and contact Zimmer, Inc. for further instructions. The recall is classified as Class II by the FDA.
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 (1)
- Item Number 82016757830 Lot Number 97009559
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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