Zimmer GmbH Recalls CBS Micro Countersink Cannulated AO Screws
Zimmer GmbH is recalling CBS micro, countersink, cannulated, AO screws (Item Number 503004541) because they may have been manufactured from a different material than specified.
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 the source text describes a potential material deviation without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer GmbH is recalling CBS micro, countersink, cannulated, AO screws, Item Number 503004541. 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 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. All items marked with "Normed" are affected.
Healthcare providers should stop using the affected devices and contact Zimmer GmbH for further instructions. Patients who have had these devices implanted should consult their healthcare provider for guidance.
The recalled product
- Product
- CBS micro, countersink, cannulated, AO, Item Number 503004541
- 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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