Zimmer GmbH Recalls CBS 4.0 Countersink Due to Material Concerns
Zimmer GmbH is recalling CBS 4.0 countersinks 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 defect, 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 the CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353. 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 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 and consumers should stop using the affected products and contact Zimmer GmbH for further instructions.
The recalled product
- Product
- CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353
- 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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