Recall Z-1123-2019— Encore Medical, Lp

Name: FDA recall Z-1123-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-21

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2018-09-21, terminated 2020-09-16. It names one FDA 510(k) clearance: K163497. 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. Reason: 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.

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2018-09-21
Terminated: 2020-09-16
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K163497 — EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture BoltEncore Medical L.P.·cleared 2017-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.