Agency classClass IIOur severity:High FDA (Devices)·Z-1457-2019·Announced 2019-05-29

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.

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 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
Category: Medical Device — Orthopedic Instrument
Hazard: material-deviation

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

Distributed in 42 states:

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.

See all 76 products in this recall →

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