Hip Reconstruction System Component Mislabeled for Size
Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.
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: This is a Class II medical device recall for a minor labeling error. The device is physically correct; only the size designation on the label is incorrect. Per the severity rubric, labeling errors without reported complications warrant a Moderate (Score 2) classification.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 3 units of the LINK MP Reconstruction System Neck Segment, a prosthetic component used in revision hip arthroplasty. This device is intended for patients with inadequate bone stock requiring specialized reconstruction techniques.
The recall is due to a labeling error on both the main label and patient documentation. The labels incorrectly indicate the product size as XXL, when the implant is actually standard-size. All other label information—including length, CCD angle, and offset specifications—is correct and accurate.
Three units have been distributed in the United States, in Alabama and Florida. Healthcare facilities that received these products should verify their records to ensure accurate documentation of the implant's actual specifications.
If you received this product or have concerns, contact your healthcare facility or Waldemar Link. The device itself is not defective; only the labeling information is incorrect.
The recalled product
- Product
- LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or…
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- Affected units
- 3
Distribution
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