The Recall Desk
HighFDA (Devices)·Z-2346-2023·Announced 2023-08-16

LINK MP Monoblock Hip Stem trial instruments recalled for difficulty in removal

Waldemar Link is recalling 24 LINK MP Monoblock Hip Stem trial instruments due to increased force required to remove them after impaction, which may prolong surgery or require procedure 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: This is a risk-of-harm medical device where injury has not yet been reported. The trial stem instruments may require prolonged surgical removal, increasing the risk of anesthesia and surgical complications. No illnesses or injuries are documented in the source text.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling 24 LINK MP Monoblock Hip Stem trial instruments (Size 15, Item Number 136-115/00) distributed nationwide in the United States. These trial stems are used by surgeons during hip replacement procedures to test positioning before implanting the final prosthesis. Lot numbers B923004, B932049, C005089, and C211009 are affected.

The recalled trial stem instruments require increased force to remove after impaction during the surgical procedure. This difficulty in removal may prolong surgery or require modification of the surgical approach during the operation.

Healthcare facilities that have this product in inventory should be aware of the increased removal force required and plan accordingly. Surgeons should anticipate potential difficulty during removal and ensure adequate time is allocated for the removal step.

The recalled product

Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic / Surgical Instruments
Hazard
  • device-removal-difficulty
  • surgical-complication

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: 04026575182091 Lot Numbers: B923004 B932049 C005089 C211009

Distribution

Distributed nationwide across the United States.

Related recalls

Same category