LINK MP Hip Stem Difficult to Remove After Surgical Implantation
Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.
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 FDA Class II recall is precautionary in nature with no reported adverse events. The hazard—difficulty removing the device following implantation—is operational rather than affecting inherent device function. Per the rubric, precautionary recalls without reported injury constitute moderate severity.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling LINK MP Monoblock Hip Stem, Trial Stem Instruments in Size 22 (Item Number 136-22/00) due to increased removal force after surgical implantation.
The recalled hip prosthetic stem may require increased force to remove after impaction during surgery. This could potentially prolong the surgical procedure or require the surgical approach to be modified.
The device was distributed nationwide in the United States. The affected lot numbers are B922119, B933168, C005032, and C211016, with 24 units distributed.
The recalled product
- Product
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 24
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 (1)
- UDI-DI: 04026575182169 Lot Numbers: B922119 B933168 C005032 C211016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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