Zimmer V-TEK Cannulated AO Screws Recalled for Material Specification Deviation
Zimmer GmbH is recalling V-TEK standard-countersink, cannulated, AO screws because they may have been manufactured from a material different from the defined specifications.
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. The hazard involves a potential material deviation in a medical device, which poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities.
Plain-English summary
Zimmer GmbH is recalling V-TEK standard-countersink, cannulated, AO screws, Item Number ST28.66.111. 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 are identified by the marking "Normed". These medical devices were distributed to hospitals and medical facilities in the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer GmbH for further instructions on the recall process. Patients who have had these devices implanted should consult their healthcare provider for guidance.
The recalled product
- Product
- V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111
- 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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