Zimmer Biomet Recalls V-Tek Twist Drills Due to Tolerance Issues
Zimmer Biomet is voluntarily recalling 169 V-Tek Twist Drills because a potential tolerance stack-up was identified between the drill and the mating Kirschner Wire component.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary measure based on a potential manufacturing tolerance issue, with no reported injuries or illnesses in the source text.
Plain-English summary
Zimmer Biomet has initiated a voluntary recall of the V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd twist drills. The recall involves 169 units identified by Part No. 502015635 and Lot Numbers 9721/188D11. These medical devices are used to drill holes into bones and tissues for foot, ankle, and hand implant systems.
The recall was initiated due to a potential tolerance stack-up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. This issue could affect the fit or function of the device during surgical procedures.
The affected products were distributed domestically in Colorado and Illinois, as well as to numerous foreign countries including Argentina, Australia, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom. Healthcare providers and facilities that have received these specific lot numbers should stop using the devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
- Manufacturer
- Zimmer Gmbh
- Affected units
- 169
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)
- Part No.: 502015635
- Lot Numbers:9721/188D11
Distribution
Part of a larger recall action
This product is one of 4 recalled by Zimmer Gmbh 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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