The Recall Desk
ModerateFDA (Devices)·Z-0165-2016·Announced 2015-11-04

Encore Medical Recalls Exprt Precision System Knee Implants for Missing Labeling

Encore Medical is recalling 209 Exprt Precision System Revision Knee implants because the labeling is missing size and diameter information.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (missing size/diameter information) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Encore Medical, Lp is recalling 209 units of the Exprt Precision System: Revision Knee, Model Number 160-010-726/738. These medical devices are used with the Exprt Knee System in total knee arthroplasty to replace the native patella.

The recall was initiated because the product labeling is missing size and diameter information. The affected units were distributed in the United States to the states of South Carolina, Wisconsin, Rhode Island, New York, Missouri, Arkansas, Oklahoma, Georgia, Florida, Alabama, California, Arizona, and Colorado.

The specific lot codes for the recalled units are 471T1-001/011, 472T1-000/014, 473T1-000/015, 474T1-000/010, and 475T1-000/008. Healthcare providers and facilities should check their inventory for these specific model numbers and lot codes and stop using the affected devices.

The recalled product

Product
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
Manufacturer
Encore Medical, Lp
Affected units
209

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 (5)

  • 471T1-001/011
  • 472T1-000/014
  • 473T1-000/015
  • 474T1-000/010
  • 475T1-000/008

Distribution

Distributed in 13 states: