The Recall Desk
SevereFDA (Devices)·Z-1123-2019·Announced 2019-04-17

Encore Medical Recalls Exprt Precision System Hip Implant Components

Encore Medical is recalling 22 units of Exprt Precision System hip implant components due to loose or improperly seated bolts that may cause pain or require revision surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical implant that may result in significant injury, including the need for revision surgery.

Plain-English summary

Encore Medical, Lp is recalling 22 units of the Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, manufactured by djo surgical. The affected reference numbers are 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, and 495-01-085. The recall covers all lots of these specific items.

The recall was initiated due to complaints regarding loose proximal body bolts or bolts that were found via x-ray to be sitting above the proximal body and not properly seated. The FDA classifies this as a Class II recall. Patient risks associated with this defect include pain, dissociation, and the possibility of requiring revision surgery.

The affected products were distributed to facilities in the following states: TN, MN, TX, CO, IL, IN, OH, SC, MS, MI, RI, PA, ME, NY, WA, MO, AR, OK, LA, AL, FL, GA, UT, AZ, CA, and NV. Healthcare providers and patients should contact their surgeon or the recalling firm for instructions on how to proceed.

The recalled product

Product
Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
Manufacturer
Encore Medical, Lp
Affected units
22

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)

  • All lots.

Distribution