Zimmer V-TEK Orthopedic Screws Recalled for Potential Material Deviation
Zimmer GmbH is recalling V-TEK standard-countersink screws because they may have been manufactured from a different material than specified.
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 material deviation, which poses a risk of harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer GmbH is recalling V-TEK standard-countersink, cannulated, round shaft screws (Item Number 28.66.110). 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 38 US states, including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, Texas, and Washington. All items marked with "Normed" are affected by this recall.
Healthcare providers and patients should contact Zimmer GmbH for further information regarding the recall and potential replacement or repair options. Patients who have had these devices implanted should consult their healthcare provider to discuss the findings and any necessary follow-up care.
The recalled product
- Product
- V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110
- 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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