Encore Medical, Lp recalls Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065…

Recall date

September 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1123-2019

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US: 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, NV,.

Why it was recalled

Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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