Z-1123-2019Class II

Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF...

Name: Z-1123-2019 Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF...
Creator: Encore Medical, Lp
Published: 2018-09-21
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2018-09-21 / Terminated

FDA source

Encore Medical, Lp began a recall of 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... on 2018-09-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1123-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-21
Posted: 2019-04-10
Terminated: 2020-09-16
Recalling firm: Encore Medical, LP
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
Product code: KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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
FDA root cause: Other
Action: On 09/21/18, Urgent Field Safety Notices, updated surgical techniques, and Acknowledgement and Receipt Forms were emailed to Surgical Sales Agents. The Surgical Technique provides instructions on use of the manual T-handle as the primary tightening method. It also provides instructions for use of the torque wrench to ensure that the readout for the torque wrench is at "0" before torque is applied. Sales agents were asked to affirm that they have read and understood the updated Surgical Technique information provided in the Field Safety Notice Bulletin. They were also asked to affirm that they disseminated this information to all employed and contracted sales reps in their organization. On 01/29/19, Urgent Field Safety Notices were emailed to Surgical Agents. This notice communicated the exchange process for physical product in inventory. The firm will notify Surgical Agents to make arrangements for the exchange of affected inventory with proximal bodies that are packaged with new capture bolts containing a polyethene plug. Surgical Agents with additional questions were encouraged to call 512-834-6255.
Quantity in commerce: 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,.
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1123-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1123-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-10

Product code KWZ

K163497Class IIEXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture BoltEncore Medical L.P. / cleared 2017-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)