The Recall Desk
HighFDA (Devices)·Z-1299-2024·Announced 2024-03-20

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.

What this means for you

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)
Category
Medical Device — Orthopedic Prosthesis
Hazard
  • labeling-error
  • surgical-misapplication

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

Distributed nationwide across the United States.

Related recalls

Same category