Zimmer Recalls Metasul LDH Head Due to Patient Label Discrepancies
Zimmer, Inc. is correcting patient labels for Metasul LDH Head Rx Sterile products manufactured before March 2010 due to discrepancies in 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 is initiated to correct patient labels due to discrepancies in reference and lot numbers, which is a documentation and labeling issue rather than a physical defect or contamination hazard.
Plain-English summary
Zimmer, Inc. is initiating a correction for the patient labels of Metasul LDH Head Rx Sterile products. The affected units were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The company identified the issue after receiving four complaints regarding a discrepancy between the product patient labels and the product labels concerning reference and lot numbers.
The source text notes that while the information printed on the product label is correct, the discrepancy exists in the patient labels. The recall involves 1,739 units distributed nationwide. Specific reference numbers and lot numbers are listed in the structured product information.
Consumers and healthcare providers should verify the reference and lot numbers of their Metasul LDH Head Rx Sterile products against the provided lists to determine if they are affected. Zimmer, Inc. is the recalling firm responsible for this correction.
The recalled product
- Product
- Metasul¿ LDH¿ Head Rx Sterile
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,739
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: 01.00181.380
- 01.00181.400
- 01.00181.420
- 01.00181.440
- 01.00181.460
- 01.00181.480
- 01.00181.500
- 01.00181.520
- 01.00181.540
- 01.00181.560
- 01.00181.580
- 01.00181.600
- Lots:2336407
- 2384226
- 2417501
- 2379463
- 2414200
- 2435636
- 2437758
- 2439049
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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