The Recall Desk
ModerateFDA (Devices)·Z-2353-2023·Announced 2023-08-16

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.

What this means for you

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)
Hazard
  • difficult-removal
  • surgical-complication-risk

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.