The Recall Desk
LowFDA (Devices)·Z-0214-2013·Announced 2012-11-14

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.

What this means for you

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.
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.

See all 40 products in this recall →