Agency classClass IIOur severity:High FDA (Devices)·Z-1378-2022·Announced 2022-07-20

Modular orthopedic prosthesis recall due to intraoperative component locking

Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.

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: FDA Class II medical device with a mechanical defect preventing proper intraoperative handling. No illnesses or injuries have been reported, but the defect poses a risk of surgical complications and procedure changes during implantation.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling the Endo Model Modular Femur and Tibia, PorEx orthopedic prostheses because of a defect in the modular tibial component. Approximately 3,785 units have been recalled.

The blind screws of the modular tibial component cannot be loosened intraoperatively. This risk may lead to prolongation of surgery and the need to change the surgical procedure during the operation.

The recalled prostheses were distributed domestically to 15 U.S. states and internationally to more than 30 countries. The specific lot numbers, model numbers, and UDI codes are available in the FDA recall notice.

Healthcare providers and patients should review the affected product list to determine if they received recalled units. Consult your physician if you have questions about your prosthesis.

The recalled product

Product: Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)
Category: Medical Device — Orthopedic / Joint Prosthesis
Hazard: screw-defect
intraoperative-complication
device-malfunction
Affected units: 3,785

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 (8)

UDI-DI 04026575034727 X-Small
Right
04026575034741 Small
04026575034758 Small
Left
04026575164042 Medium
04026575164059 Medium
04026575164028 Large

Distribution

Distributed in 15 states:

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.

See all 4 products in this recall →

Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)

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