The Recall Desk
HighFDA (Devices)·Z-2347-2023·Announced 2023-08-16

LINK MP Monoblock Hip Stem Trial Instruments May Require Increased Removal Force

LINK MP Monoblock Hip Stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery for affected patients.

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 with no reported injuries or illnesses. The recall addresses a risk-of-harm condition: difficulty removing the trial stem could prolong surgery and extend anesthesia exposure, increasing surgical complication risk.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling LINK MP Monoblock Hip Stem trial stem instruments, Size 16 (Item Number 136-116/00). The recall affects 24 units distributed nationwide in the United States. These are trial instruments used during hip joint surgery to test implant fit before permanent placement. Lot numbers affected include B923003, B932050, C005075, and C211010.

The recall was issued because increased force may be required to remove the trial stem after impaction. This can result in prolongation of the surgical procedure or require modification of the surgical technique. The issue affects LINK MP Monoblock trial stems in sizes ranging from 14mm to 25mm, though this recall specifically involves Size 16 instruments.

Patients who are scheduled to undergo hip surgery using these instruments, or who have recently undergone such procedures, may be affected. Healthcare providers should review their inventory and patient records for affected lot numbers. Surgeons should be aware of the potential for increased removal force and may need to adjust surgical planning accordingly.

The recalled product

Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Hip Orthopedic Implant
Hazard
  • removal-difficulty
  • surgical-delay

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: 04026575182107 Lot Numbers: B923003 B932050 C005075 C211010

Distribution

Distributed nationwide across the United States.

Related recalls

Same category