Zimmer GmbH Recalls V-TEK Micro-Countersink Due to Material Concerns
Zimmer GmbH is recalling V-TEK micro-countersinks because an investigation found they may be made from a different material than specified.
What this means for you
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 the hazard involves a potential material deviation in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer GmbH is recalling V-TEK micro-countersinks, round shaft, Item Number 28.66.112. The recall was initiated after an investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
The affected products were distributed to numerous US states, including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, Texas, and Washington. All items marked with "Normed" are affected by this recall.
Consumers and healthcare providers should stop using the affected products and contact Zimmer GmbH for further instructions or a replacement.
The recalled product
- Product
- V-TEK", micro-countersink, round shaft, Item Number 28.66.112
- Manufacturer
- Zimmer GmbH
- Hazard
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 (1)
- All items marked with "Normed" are affected
Distribution
Part of a larger recall action
This product is one of 76 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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