Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural failure of a medical device during use, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the 23.5 Deg Rasp Handle Assy- LEFT Nonsterile. The recall involves Item Number 82-0167-636-00, specifically Lot Numbers 97009530 and 97009782. The product was distributed nationwide in the United States and internationally to Australia, France, Germany, Italy, Switzerland, and Canada.
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.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should stop using the affected units and contact Zimmer, Inc. for instructions on how to return or replace the product.
The recalled product
- Product
- 23.5 Deg Rasp Handle Assy- LEFT 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 82-0167-636-00 Lot Number 97009530
- 97009782
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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