The Recall Desk
ModerateFDA (Devices)·Z-2349-2023·Announced 2023-08-16

Hip Stem Trial Instrument Difficult to Remove After Impaction

LINK MP Monoblock hip stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery or requiring procedure modification. No injuries or illnesses have been reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The issue is increased force required for removal potentially prolonging surgery, which represents an operational/technical complication rather than direct patient harm.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling LINK MP Monoblock Hip Stem Trial Stem Instruments, Size 18 (Item Number 136-118/00), used in hip joint surgery for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur. The recall affects 24 units distributed nationwide. Lot numbers B922123, B932052, C005067, and C211012 are involved in this recall.

The reason for the recall is that increased force may be required to remove the trial stem after impaction. This increased removal force has the potential to prolong the surgical procedure or require modification of the surgical technique.

No injuries or illnesses have been reported in connection with this issue.

The recalled product

Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard
  • removal-difficulty
  • surgical-prolongation

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: 04026575182121 Lot Numbers: B922123 B932052 C005067 C211012

Distribution

Distributed nationwide across the United States.