FDAClass IIApril 17, 2019

Exprt Precision System: Revision Hip recall

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…

Why was Exprt Precision System: Revision Hip 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots.

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…
Recalling firm
Encore Medical, Lp
Quantity
22
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,.
Recall date
April 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls