The Recall Desk
HighFDA (Devices)·Z-2345-2023·Announced 2023-08-16

Hip Stem Trial Implant May Require Excessive Force During Removal

A trial hip stem implant may require excessive force to remove after insertion during surgery, potentially prolonging the procedure or requiring surgical 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 medical device recall with no reported illnesses or injuries. The potential difficulty in removing the device during surgery poses a risk of harm through tissue trauma and prolonged anesthesia, fitting the criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling the LINK MP Monoblock Hip Stem trial instrument (Size 14, Item Number 136-114/00, Lot Numbers B923005 and B932048) due to difficulty in removal during surgery.

The trial stem may require increased force to remove after insertion. This increased force requirement could prolong the surgical procedure or necessitate modification of the surgical technique.

Healthcare facilities using this trial instrument should contact the manufacturer for further instructions and guidance.

The recalled product

Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic Implant
Hazard
  • difficult-removal
  • 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: 04026575182084 Lot Numbers: B923005 B932048

Distribution

Distributed nationwide across the United States.

Related recalls

Same category