Hip prosthesis labeling guidance issue affects 34 units
The FDA is advising on label interpretation for the SPII Model Lubinus hip prosthesis stem to prevent confusion during surgery. Two complaints prompted additional guidance on carton label size and type columns.
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 a risk-of-harm product (hip prosthesis) where injury has not yet been reported. The labeling interpretation issue could potentially lead to surgical error if misinterpreted, meeting the Score 3 rubric criterion.
Plain-English summary
The SPII Model Lubinus Hip Prosthesis Stem XL Neck (cemented), manufactured by Waldemar Link GmbH & Co. KG, is subject to a labeling interpretation issue affecting 34 units distributed nationwide.
The FDA determined that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery. Two complaints initiated this review.
A hip prosthesis is a surgical implant used to replace a damaged hip joint. The labeling on the product carton provides size and type information that surgeons use to select the correct implant. Confusion about how to interpret this information could potentially lead to selection of an inappropriate implant during surgery.
Healthcare providers who have received this device should ensure clear understanding of the labeling before any surgical procedure. No injuries have been reported.
The recalled product
- Product
- SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Medical Device — Hip Prosthesis
- Affected units
- 34
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): 127-740/17 (04026575241620)
- 127-740/26 (04026575241637)
- 127-741/17 (04026575241651)
- 127-741/26 (04026575241644)
- 127-742/17 (04026575241675)
- 127-742/26 (04026575241682)
- 127-743/17 (04026575241705)
- 127-743/26 (04026575241699)
- 127-744/17 (04026575241712)
- 127-744/26 (04026575241729)
- 127-745/17 (04026575241743)
- 127-745/26 (04026575241736)
- 127-746/17 (04026575241750)
- 127-746/26 (04026575241767)
- 127-747/17 (04026575241781)
- 127-747/26 (04026575241774)
- 127-748/17 (04026575241798)
- 127-748/26 (04026575241804)
- 127-749/17 (04026575241828)
- 127-749/26 (04026575241811)
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
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