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Recall Observatory FDA recall evidence

Device 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

Z-1123-2019

September 21, 2018

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 82379
Status
Terminated
Classification
Class II
Quantity
22
Official record key
device-enforcement:Z-1123-2019

Official wording

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

Code information: All lots.

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,.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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