The Recall Desk
HighFDA (Devices)·Z-2351-2023·Announced 2023-08-16

Hip implant trial stem: increased removal force may extend surgery

Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments due to increased force required for removal during surgery, which may prolong the procedure or require 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 Class II medical device recall with no reported injuries or hospitalizations. The hazard represents a risk-of-harm product where injury has not yet been reported: operational difficulty during the surgical trial phase that could extend procedure duration or require technique modification.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling the LINK MP Monoblock Hip Stem trial stem instruments (Size 20, Item Number 136-120/00). These trial instruments are used during hip replacement surgery to assess proper fit and positioning before implanting the permanent stem. The devices were distributed nationwide in the United States, affecting 24 units.

The recalled devices may require increased force for removal after impaction during surgical trials. This increased removal force may result in prolongation of the surgical procedure or may necessitate modification of the surgical technique. The affected lot numbers are B922121, B933166, C005012, and C211014.

Surgeons and surgical facilities using this device should be aware of the potential for increased removal force during the trial fitting stage. They should take appropriate measures to address any difficulty during removal and be prepared for possible extended operative time. Healthcare providers with questions about this recall should contact the manufacturer.

The recalled product

Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Orthopedic / Hip Implant
Hazard
  • surgical-complication
  • procedure-modification
  • 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: 04026575182145 Lot Numbers: B922121 B933166 C005012 C211014

Distribution

Distributed nationwide across the United States.

Related recalls

Same category