Zimmer CBS 4.5 Countersink Recalled for Potential Material Deviation
Zimmer GmbH is recalling CBS 4.5 countersinks because they may have been manufactured 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 involves a medical device with a potential material deviation, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer GmbH is recalling the CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351. 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 healthcare 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 regarding the recall.
The recalled product
- Product
- CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
- 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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