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 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 and involves a medical device used in surgical procedures. While no specific injuries are reported in the source text, the potential for harm from a mechanical tolerance issue in a surgical instrument places it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet has initiated a voluntary recall of 169 units of the V-TEK Twist Drill (Part No. 502015640, Lot Numbers 27374 and 104547/188A9). The recall was initiated due to a potential tolerance stack-up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. These devices are used to drill holes into bones and tissues for foot, ankle, and hand implant systems.
The affected units were distributed domestically in Colorado and Illinois, as well as to numerous foreign countries including Argentina, Australia, Brazil, Canada, China, and the United Kingdom. The agency has classified this recall as Class II.
Healthcare providers and consumers should stop using the affected devices immediately. Users should contact Zimmer Biomet for further instructions on how to return or replace the recalled products.
The recalled product
- Product
- V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
- Manufacturer
- Zimmer Gmbh
- Hazard
- 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 (3)
- Part No.: 502015640
- Lot Numbers:27374
- 104547/188A9
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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