Zimmer Recalls Nonsterile VER2 Handle Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT Nonsterile 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 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 (fracture of the leaf spring) that could lead to injury during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT Nonsterile (Item Number 82-0167-613-32, Lot Number 97010151). The recall was initiated after 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 affected products 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.
Consumers and healthcare facilities should stop using the affected handles and contact Zimmer, Inc. for further instructions or a replacement.
The recalled product
- Product
- VER2 HANDLE, PIN REWORK, 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 (1)
- Item Number 82-0167-613-32 Lot Number 97010151
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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