The Recall Desk
HighFDA (Devices)·Z-2103-2021·Announced 2021-07-28

Knee Prosthesis Recall: Packaging Mixup May Cause Wrong Size Implantation

Encore Medical recalls DJO Surgical EMPOWR 3D knee prosthetic components because packaging labels may not match the product inside, risking implantation of incorrect prosthesis sizes.

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: This is an FDA Class II medical device recall involving risk of incorrect prosthesis size implantation due to packaging mixup. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Encore Medical, LP is recalling DJO Surgical EMPOWR 3D Knee Tibial Insert components due to a packaging mixup. Packaging labeled as containing 12mm prostheses may actually contain 16mm prostheses, and 16mm packaging may contain 12mm prostheses.

Ten units of the affected product were distributed to healthcare facilities in Virginia, Minnesota, Texas, Illinois, Mississippi, California, Kansas, Louisiana, and Georgia. The affected lot number is 115T1035 (REF: 341-12-711).

Patients and healthcare facilities who have received these components should contact Encore Medical or their distributor to verify the correct prosthesis size was received and to arrange replacement if necessary.

The recalled product

Product
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Manufacturer
Encore Medical, LP
Category
Medical Device — Orthopedic Prosthesis
Hazard
  • packaging-mixup
  • prosthesis-size-mismatch

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)

  • Lot # 115T1035

Distribution

Distributed nationwide across the United States.

Related recalls

Same category