LINK MP Monoblock Hip Stem Trial Instruments Difficult to Remove After Impaction
Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments because they may require increased force to remove after impaction, potentially prolonging surgery or requiring procedural 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 recall of a surgical implant where the device may require increased force to remove during surgery, potentially prolonging the procedure or requiring modification of technique. No injuries, hospitalizations, or adverse events have been reported. This constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling the LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 (Item Number 136-25/00). The recall affects 24 units distributed nationwide in the United States with lot numbers B922113, B934176, C005048, C211019, and C240050.
The device may require increased force to remove from the patient after impaction during hip replacement surgery. This difficulty could prolong the surgical procedure or require modification of the surgical technique.
Patients who have received this device or surgical facilities with these instruments in inventory should be aware of this recall. Patients with concerns should contact their surgeon or healthcare provider. Healthcare providers should stop using the affected lot numbers and contact Waldemar Link or the FDA with any questions.
The recalled product
- Product
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 24
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: 04026575182190 Lot Numbers: B922113 B934176 C005048 C211019 C240050
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)
See all →- HighWaldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets
FDA (Devices) · 2026-08-19
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- HighLink Endo-Model plateau 15-0027/15 recalled over screw bushing fracture
FDA (Devices) · 2026-03-18
- HighLink Endo-Model SL component 16-2840/05 recalled over bushing fracture
FDA (Devices) · 2026-03-18
Same hazard · removal difficulty
See all →- HighMedtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
FDA (Devices) · 2024-01-17
- HighMedtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
FDA (Devices) · 2024-01-17
- HighMedical Device Recall: LINK MP Hip Stem Trial Instruments Removal Difficulty Risk
FDA (Devices) · 2023-08-16
- HighLINK MP Hip Stem trial instruments may require increased removal force during surgery
FDA (Devices) · 2023-08-16
- ModerateHip Stem Trial Instrument Difficult to Remove After Impaction
FDA (Devices) · 2023-08-16