Hip prosthesis labeling clarification needed to prevent surgical confusion
Waldemar Link is clarifying labeling on 153 hip prosthesis units after complaints about ambiguous Size and Type information. The guidance aims to prevent potential misinterpretation during surgery.
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 2/5 (Moderate).
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: FDA Class II recall with no reported injuries or hospitalizations. The hazard is a labeling clarity issue requiring manufacturer guidance to prevent potential misinterpretation during surgery.
Plain-English summary
Waldemar Link GmbH & Co. KG is issuing guidance on the labeling of the SPII Model Lubinus Long Stem Prosthesis with Standard Neck (cemented). A total of 153 units were distributed.
The carton label contains Size and Type columns that require clarification. Two complaints indicated that the current labeling may be subject to misinterpretation during surgical procedures. The manufacturer is providing corrected guidance to ensure proper identification of the correct prosthesis before use.
The affected units were distributed nationwide in the following states: Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Virginia, and Washington.
Surgeons and hospitals using this product should contact the manufacturer for the updated labeling guidance and review the new instructions before performing procedures with this prosthesis.
The recalled product
- Product
- SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 153
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)
- Product Code (UDI/DI): 127-910/26 (04026575024872)
- 127-910/35 (04026575024889)
- 127-911/26 (04026575024902)
- 127-911/35 (04026575024919)
- 127-912/26 (04026575024933)
- 127-912/35 (04026575024940)
- 127-913/26 (04026575024964)
- 127-913/35 (04026575024971)
- 127-914/26 (04026575024995)
- 127-914/35 (04026575025008)
- 127-915/26 (04026575025022)
- 127-915/35 (04026575025039)
- 127-916/26 (04026575025053)
- 127-916/35 (04026575025060)
- 127-917/26 (04026575025084)
- 127-917/35 (04026575025091)
- 127-918/26 (04026575025114)
- 127-918/35 (04026575025121)
- 127-919/26 (04026575025145)
- 127-919/35 (04026575025152)
Distribution
Part of a larger recall action
This product is one of 4 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) 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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