LINK MP Monoblock Hip Stem trial instruments recalled for increased removal difficulty
Waldemar Link GmbH recalled LINK MP Monoblock hip stem trial instruments (Size 23) nationwide due to increased force required for removal post-impaction, potentially prolonging surgery time.
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 hip implant trial instrument recall involving a risk-of-harm product where increased removal difficulty may extend surgical duration. This documented issue during surgical procedures meets the criteria for High severity classification.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling LINK MP Monoblock Hip Stem trial instruments (Size 23) distributed nationwide in the United States. The issue affects all sizes of this trial stem product (14mm to 25mm).
The trial instruments may require increased force to remove after impaction during surgery. This can result in prolonged surgical time or require modification of the planned surgical procedure.
These instruments are intended for hip joint procedures. The increased removal force needed may extend the duration of surgery and complicate the surgical procedure.
Healthcare providers using these instruments should be aware of the potential for increased removal force during procedures.
The recalled product
- Product
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Medical Device — Hip Implant
- Hazard
- 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: 04026575182176 Lot Numbers: B922118 B933169 C005023 C211017 C240048
Distribution
Distributed nationwide across the United States.
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