Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handles may fail to remain assembled to the rasp during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a mechanical failure of a medical device during use, which presents a risk of harm, but the source text does not report specific injuries or illnesses.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the Double Offset Rasp Handle, Right Hand Nonsterile. The recall involves Item Number 82016757922, specifically Lot Numbers 97005189 and 97005833.
The firm received complaints that the handle failed to remain assembled to the rasp during use. The source text attributes this to various failure modes, including the fracture of the leaf spring.
The affected units were distributed nationwide in the United States, including in Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, and Virginia. The products were also distributed in Australia, France, Germany, Italy, Switzerland, and Canada.
The recalled product
- Product
- Double Offset Rasp Handle, Right 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 (2)
- Item Number 82016757922 Lot Number 97005189
- 97005833
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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