The Recall Desk
HighFDA (Devices)·Z-2356-2023·Announced 2023-08-16

LINK MP Monoblock Hip Stem Trial Instruments Difficult to Remove After Impaction

Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments because they may require increased force to remove after impaction, potentially prolonging surgery or requiring procedural modification.

What this means for you

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: FDA Class II recall of a surgical implant where the device may require increased force to remove during surgery, potentially prolonging the procedure or requiring modification of technique. No injuries, hospitalizations, or adverse events have been reported. This constitutes a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling the LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 (Item Number 136-25/00). The recall affects 24 units distributed nationwide in the United States with lot numbers B922113, B934176, C005048, C211019, and C240050.

The device may require increased force to remove from the patient after impaction during hip replacement surgery. This difficulty could prolong the surgical procedure or require modification of the surgical technique.

Patients who have received this device or surgical facilities with these instruments in inventory should be aware of this recall. Patients with concerns should contact their surgeon or healthcare provider. Healthcare providers should stop using the affected lot numbers and contact Waldemar Link or the FDA with any questions.

The recalled product

Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Implant / Hip Stem
Hazard
  • removal-difficulty
  • prolonged-surgery

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: 04026575182190 Lot Numbers: B922113 B934176 C005048 C211019 C240050

Distribution

Distributed nationwide across the United States.

Related recalls

Same category