Hip Prosthesis Stem Labels Lack Clear Guidance on Size and Type
A hip prosthesis stem was recalled due to ambiguous carton label guidance that could cause incorrect implant selection during surgery. The recall affects 382 units.
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 an orthopedic implant with potential for serious patient harm if misused. While no injuries are reported, the labeling ambiguity creates a risk-of-harm scenario where surgeons could implant an incorrectly sized prosthesis, meeting the criterion for High severity.
Plain-English summary
The FDA has recalled 382 units of the SPII Model Lubinus Hip Prosthesis Stem Standard Neck (cemented version) manufactured by Waldemar Link GmbH & Co. KG.
Two complaints indicated that additional guidance is required on the correct interpretation of the Size and Type columns on the carton label. Without clearer guidance, these columns could be misinterpreted during surgery, potentially resulting in selection of an incorrect implant.
The recalled devices were distributed nationwide.
The recalled product
- Product
- SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 382
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): 127-610/17 (04026575387168)
- 127-610/26 (04026575387304)
- 127-610/35 (04026575387441)
- 127-612/17 (04026575387175)
- 127-612/26 (04026575387311)
- 127-612/35 (04026575387458)
- 127-614/17 (04026575387182)
- 127-614/26 (04026575387328)
- 127-614/35 (04026575387465)
- 127-616/17 (04026575387199)
- 127-616/26 (04026575387335)
- 127-616/35 (04026575387472)
- 127-618/17 (04026575387205)
- 127-618/26 (04026575387342)
- 127-618/35 (04026575387489)
- 127-620/17 (04026575387212)
- 127-620/26 (04026575387359)
- 127-620/35 (04026575387496)
- 127-622/17 (04026575387229)
- 127-622/26 (04026575387366)
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)
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