Zimmer Biomet Recalls Twist Drills Due to Tolerance Issues
Zimmer Biomet is voluntarily recalling 169 Twist Drills and V-Tek Twist Drills because of a potential tolerance stack-up issue with Kirschner Wire components.
What this means for you
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 due to a potential tolerance issue, with no reported injuries or illnesses mentioned in the source text.
Plain-English summary
Zimmer Biomet has initiated a voluntary recall of 169 units of the Twist Drill and V-Tek Twist Drill. 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. The affected products are identified by Part No. 502015629 and Lot Numbers 7975/188D10, 10409/188A12, and 10408/188A12.
The recalled devices 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 these devices should stop using them and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- TWIST D 28X150MM CBS 45 Cann 14 MM 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 (4)
- Part No.: 502015629
- Lot Numbers: 7975/188D10
- 10409/188A12
- 10408/188A12
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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