Agency classClass IIOur severity:High FDA (Devices)·Z-2104-2021·Announced 2021-07-28

DJO Surgical EMPOWR 3D Knee Tibial Insert packaging may contain wrong implant size

Packaging for DJO Surgical EMPOWR 3D Knee Tibial Insert knee prosthesis implants may be mislabeled, with 12mm packages potentially containing 16mm implants or vice versa, risking incorrect surgical implantation.

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 recall involves surgical implants with a packaging/labeling error that creates a risk of incorrect implant size being used during surgery. Although no illnesses or injuries have been reported, the hazard poses significant patient risk, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Encore Medical, LP is recalling certain DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus prostheses (Lot #155T1035) due to a packaging mixup affecting 10 units distributed nationwide.

The recall addresses a potential packaging error where containers labeled as containing 12mm knee prosthesis implants may actually contain 16mm implants, and containers labeled as 16mm may contain 12mm implants. This mixup could result in a surgeon implanting an incorrect implant size during knee replacement surgery.

The affected implants were distributed to facilities in Virginia, Minnesota, Texas, Illinois, Mississippi, California, Kansas, Louisiana, and Georgia. Patients who have undergone knee replacement surgery using products from this lot, as well as healthcare facilities that received these implants, should contact their manufacturer for guidance.

If you received or implanted one of these devices, contact Encore Medical, LP immediately to report the issue and determine appropriate next steps. Healthcare providers should verify implant sizes before surgical use.

The recalled product

Product: DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Manufacturer: Encore Medical, LP
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
wrong-size-implant
Affected units: 10

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 # 155T1035

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Encore Medical, LP 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 2 products in this recall →

Same manufacturer · Encore Medical, LP

See all →

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Same hazard · mis labeling