The Recall Desk
ModerateFDA (Devices)·Z-0218-2013·Announced 2012-11-14

Zimmer Recalls Distal Centralizers Due to Labeling Discrepancy Complaints

Zimmer Inc. is correcting patient labels for MS-30 Distal Centralizers manufactured before March 2010 after receiving four complaints regarding reference and lot number discrepancies.

What this means for you

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 without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Inc. is initiating a correction to the patient labels of MS-30 Distal Centralizers, cemented, sterile, prescription products. This action involves 58 units manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The products were distributed nationwide.

The recall was initiated after the company received four complaints identifying a discrepancy between the product patient labels and the product labels regarding reference and lot numbers. The source text notes that while the information printed on the product label is correct, the discrepancy was reported in the context of the patient labels.

Healthcare providers and patients should verify the reference and lot numbers of the affected devices against the provided lists. The specific reference numbers involved are 01.00351.005, 01.00351.006, 01.00351.014, 01.00351.214, 01.00351.216, 01.00351.416, 01.00351.620, 01.00356.008, and 01.00356.010. The affected lot numbers are 2330077, 2397912, 2319413, 2280640, 2386348, 2399448, 2389980, and 2426020, 2430035.

The recalled product

Product
MS-30¿ Distal centralizer, cemented, sterile, Rx
Manufacturer
Zimmer, Inc.
Affected units
58

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 (17)

  • REF Numbers: 01.00351.005
  • 01.00351.006
  • 01.00351.014
  • 01.00351.214
  • 01.00351.216
  • 01.00351.416
  • 01.00351.620
  • 01.00356.008
  • 01.00356.010.Lot 2330077
  • 2397912
  • 2319413
  • 2280640
  • 2386348
  • 2399448
  • 2389980
  • 2426020
  • and 2430035.

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 →