Zimmer Anatomical Shoulder Glenoid Components Recalled for Labeling Discrepancies
Zimmer Inc. is correcting patient labels on specific shoulder glenoid components due to discrepancies between product and patient labels regarding reference and lot numbers.
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 2/5 (Moderate).
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 involves a labeling discrepancy where the product label information is stated to be correct, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Zimmer Inc. is initiating a correction for patient labels on specific Anatomical Shoulder Glenoid and PE Keeled Glenoid components. These products were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 164 units distributed nationwide in the United States.
The correction is being made after the company received four complaints regarding a discrepancy between the product patient labels and the product labels. Specifically, the reference and lot numbers on the patient labels did not match the product labels. The source text notes that the information printed on the product label is correct.
Healthcare providers and patients should verify the reference and lot numbers on the patient labels against the product labels for the affected units. The affected reference numbers are 01.04214.340, 01.04214.345, 01.04214.370, 01.04214.400, and 01.04214.405.
The recalled product
- Product
- zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 164
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 (20)
- REF Numbers: 01.04214.340
- 01.04214.345
- 01.04214.370
- 01.04214.400
- and 01.04214.405. Lot 2416527
- 2430357
- 2447460
- 2450204
- 2348311
- 2364768
- 2403597
- 2418592
- 2452946
- 2453947
- 2503319
- 2517200
- 2329832
- 2349655
- 2388161
- 2453280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by Zimmer, Inc. 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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