Home / Recalls / Encore Medical, Lp / Z-1123-2019

Z-1123-2019 Class II Terminated

Recalled by Encore Medical, Lp — Austin, TX

Recall Details

Product Type
Devices
Report Date
April 17, 2019
Initiation Date
September 21, 2018
Termination Date
September 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22

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

Distribution Pattern

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,.

Code Information

All lots.

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