Alloclassic SL-Offset Stem Patient Labels Corrected for Number Discrepancies
Zimmer is correcting patient labels on 126 Alloclassic SL-Offset Stems made before March 2010 after four complaints that their reference and lot numbers differed from the correct product labels.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Score 1 applies because the recall concerns a patient-label documentation discrepancy, which fits the rubric's Low criterion for documentation issues. The product labels contain the correct reference and lot information.
Plain-English summary
Zimmer Inc. is correcting the patient labels for Alloclassic SL-Offset Stems. The correction follows four complaints that the reference and lot numbers on patient labels did not match the product labels. The information on the product labels is correct.
The affected products were manufactured before March 2010 at Zimmer GmbH's Winterthur, Switzerland production site. The notice identifies 126 units, nationwide distribution, and REF numbers 01.00121.020, 01.00121.030, 01.00121.040, 01.00121.050, 01.00121.060, 01.00121.070, and 01.00121.090.
The provided notice does not state any action for consumers or patients.
The recalled product
- Product
- Alloclassic¿ SL-Offset Stem sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 126
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 (7)
- REF Numbers: 01.00121.020
- 01.00121.030
- 01.00121.040
- 01.00121.050
- 01.00121.060
- 01.00121.070
- and 01.00121.090.
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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