Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure
Zimmer, Inc. is recalling 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain attached 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. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).
Plain-English summary
Zimmer, Inc. is recalling 23.5 Degree Rasp Handle Assemblies (Item Number 82-0167-636-20, Lot Numbers 97009531 and 97009781). The recall involves nonsterile, right-sided handles distributed nationwide in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada.
The firm received complaints that the handle failed to remain assembled to the rasp during use. The failure modes included fracture of the leaf spring. This is an FDA Class II recall.
Healthcare providers should stop using the affected devices and contact Zimmer, Inc. for instructions on return or replacement.
The recalled product
- Product
- 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
- Manufacturer
- Zimmer, Inc.
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 82-0167-636-20 Lot Number 97009531
- 97009781
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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