Zimmer Fitmore Hip Stem Label Correction for Reference and Lot Discrepancies
Zimmer Inc. is correcting patient labels for Fitmore Hip Stems manufactured before March 2010 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses a documentation and labeling discrepancy where the product label information is confirmed to be correct, fitting the criteria for Low severity (documentation issues, packaging-only problems).
Plain-English summary
Zimmer Inc. is initiating a correction for the patient labels of Fitmore Hip Stem products. This action involves 1,190 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 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.
Consumers and healthcare providers should verify the reference and lot numbers on the patient labels against the product labels for the affected units. The specific REF numbers and Lot numbers are listed in the structured product information.
The recalled product
- Product
- Fitmore" Hip Stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,190
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: 01.00551.102
- 01.00551.103
- 01.00551.104
- 01.00551.106
- 01.00551.108
- 01.00551.109
- 01.00551.110
- 01.00551.111
- 01.00551.112
- 01.00551.201
- 01.00551.202
- 01.00551.203
- 01.00551.204
- 01.00551.205
- 01.00551.206
- 01.00551.207
- 01.00551.208
- 01.00551.209
- 01.00551.210
- 01.00551.211
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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