FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: 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
- Recall number
- Z-1123-2019
- 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
- Status
- Terminated
- Initiated
- 2018-09-21
- Posted
- not on file
- Terminated
- 2020-09-16
- 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
- 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
- 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,.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K163497"]
- PMA numbers
- not on file
- Product code
- KWZ
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28