Zimmer VER2 Handle Recalled Due to Assembly Failure During Use
Zimmer, Inc. is recalling 412 units of VER2 Handle, Pin Rework, LT 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 specific injuries or hospitalizations, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, LT Nonsterile. The recall involves Item Number 82-0167-612-31, specifically Lot Numbers 97009753 and 97010150.
The firm is conducting this recall after receiving complaints that the handle failed to remain assembled to the rasp during use. The source text identifies various failure modes for this issue, including the fracture of the leaf spring.
The affected units were distributed worldwide, including nationwide distribution in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada. Consumers and healthcare providers should stop using the affected handles and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- VER2 HANDLE, PIN REWORK, LT 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 82-0167-612-31
- Lot Number 97009753
- 97010150
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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