Zimmer Biomet Recalls Twist Drills Due to Tolerance Stack Up
Zimmer Biomet is voluntarily recalling 169 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 involves a medical device with a potential mechanical defect (tolerance stack up) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria 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 Twist Drill & V-Tek Twist Drill. The recall is 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 products are identified by Part No. 502015621 and Lot Numbers 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, and 11137/188B12. The devices were distributed domestically in Colorado and Illinois, as well as to numerous foreign countries including Argentina, Australia, Canada, China, and Germany.
Healthcare providers and consumers should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or replace them. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- TWIST DR 25X95MM Cann 12MM Thd 30MM AO; 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 (6)
- Part No.: 502015621
- Lot Numbers: 8695/188B11
- 8916/188B11
- 9555/188D11
- 10413/311A12
- 11137/188B12
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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