Reported Apr 17, 2019 · Terminated
Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF:…
Encore Medical, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- Exprt Precision SystemRevision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical
- REF
495-00-065495-00-075495-00-085495-01-065495-01-075495-01-085
- Lot codes and dates
- All lots.
- Amount recalled
- 22
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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