FDA recall Z-1123-2019

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 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

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,.

Key facts

Status

Terminated

Initiation date

2018-09-21

Report date

2019-04-17

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1123-2019