Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects in medical devices that could lead to significant injury.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the VER2 D8L Offset Rasp Handle, RT Nonsterile. The recall involves Item Number 82016761302 and Lot Numbers 97009564, 97009565, and 97009570.
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. The product was distributed nationwide in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada.
This recall is classified as Class II by the FDA. Users should stop using the affected handles and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- VER2 D8L OFFSET RASP HANDLE, RT 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 (3)
- Item Number 82016761302 Lot Number 97009564
- 97009565
- 97009570
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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