Modular Orthopedic Implant Screws May Not Loosen During Surgery
FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.
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 FDA Class II medical device recall involves an orthopedic implant with a documented risk of mechanical malfunction during surgery. Although no injuries or complications have been reported, the potential for surgical complications and procedure modification qualifies this as a risk-of-harm product without yet-reported injury, meeting the threshold for High severity.
Plain-English summary
The U.S. Food and Drug Administration is recalling certain Endo Model Modular Rotational Tibia orthopedic prosthesis implants (Models 15-2814/02, 15-2814/03, and 15-2814/04) manufactured by Waldemar Link GmbH & Co. KG. This recall affects 3,785 units distributed domestically and internationally.
There is a risk that the blind screws of the modular tibial component cannot be loosened during surgery. If this occurs intraoperatively, surgeons may need to modify their surgical approach, which can prolong the procedure.
Patients with one of these implants should speak with their healthcare provider. Healthcare facilities and hospitals should review their inventory of affected units and contact the manufacturer for further guidance.
The recalled product
- Product
- Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 3,785
Distribution
Part of a larger recall action
This product is one of 4 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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