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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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)
- 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: 04026575182145 Lot Numbers: B922121 B933166 C005012 C211014
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.
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