FDA Medical Device Recalls (openFDA)
Encore Medical, LP: DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
- Recall number
- Z-1257-2022
- Recalling firm
- Encore Medical, LP
- Product
- DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
- Status
- Open, Classified
- Initiated
- 2022-05-05
- Posted
- not on file
- Terminated
- not on file
- Reason
- A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
- Root cause
- Labeling mix-ups
- Action
- On 05/05/2022, recall notices were emailed to DJO Surgical Agents by Enovis. Notices state that DJO Surgical requires the following actions: 1) Pass on the recall notice within your organization or to any organization where the potentially affected product has been transferred. 2) Contact Customer Service at 1-800-456-8696 to place a replacement order and to receive an RMA number to return affected devices. 3) Customers with questions or issues can contact Customer Service.
- Quantity
- 20
- Distribution
- U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.
- Lot, serial or model codes
- Lot number 078T1141
- 510(k) numbers
- ["K143242"]
- PMA numbers
- not on file
- Product code
- JWH
- 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