Data Foundry

Medical device recalls 2019

Exprt Precision System: Revision Hip — Class II medical device recall Z-1123-2019

Terminated recall by Encore Medical, Lp, reported 2019-04-17, distributed in AL, AR, AZ, CA, CO, FL, GA, IL…. Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the pro

Recall numberZ-1123-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmEncore Medical, Lp, Austin, TX, United States
Recall initiated2018-09-21
Classified2019-04-10
Reported by FDA2019-04-17
Terminated2020-09-16
DistributedAL, AR, AZ, CA, CO, FL, GA, IL, IN, LA, ME, MI, MN, MO, MS, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, WA
Quantity22
Model numbers495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1123-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.