SPII Lubinus Hip Prosthesis Recalled Due to Carton Label Interpretation Guidance
Waldemar Link is recalling SPII Model Lubinus Long Stem Prosthesis XL Neck implants due to carton labeling that could be misinterpreted during surgery. Clearer guidance is being provided to prevent surgical misapplication.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical implant where labeling could lead to incorrect implant selection during surgery. No illnesses or injuries have been reported, and the hazard is theoretical, meeting the criteria for High severity as a risk-of-harm product without reported injury.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling SPII Model Lubinus Long Stem Prosthesis XL Neck (cemented) devices following two complaints about the carton labeling. The issue concerns the Size and Type columns on the carton label, which can be misinterpreted during surgery and may result in selection of an incorrect implant.
The recalled prostheses are distributed across 20 U.S. states including Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Virginia, and Washington. Multiple product codes are affected, as listed by the FDA.
The manufacturer is providing updated guidance to healthcare providers and hospitals to clarify the correct interpretation of the Size and Type columns. This guidance is intended to prevent misinterpretation during surgical procedures.
Patients who have received this implant should consult their healthcare provider with any questions. Healthcare facilities with these devices should implement the updated labeling guidance provided by the manufacturer.
The recalled product
- Product
- SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
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): 127-940/26 (04026575335572)
- 127-940/35 (04026575335589)
- 127-941/26 (04026575335596)
- 127-941/35 (04026575335602)
- 127-942/26 (04026575335619)
- 127-942/35 (04026575335626)
- 127-943/26 (04026575335633)
- 127-943/35 (04026575335640)
- 127-944/26 (04026575335657)
- 127-944/35 (04026575335664)
- 127-945/26 (04026575335671)
- 127-945/35 (04026575335688)
- 127-946/26 (04026575335695)
- 127-946/35 (04026575335701)
- 127-947/26 (04026575335718)
- 127-947/35 (04026575335725)
- 127-948/26 (04026575335732)
- 127-948/35 (04026575335749)
- 127-949/26 (04026575335756)
- 127-949/35 (04026575335763)
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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