FDA Medical Device Recalls (openFDA)
Encore Medical, LP: DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
- Recall number
- Z-2103-2021
- Recalling firm
- Encore Medical, LP
- Product
- DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
- Status
- Open, Classified
- Initiated
- 2021-05-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
- Root cause
- Mixed-up of materials/components
- Action
- On 5/12/2021, Encore Medical, LP (DJO) issued a "Urgent Field Safety Notice" via E-Mail. In addition to informing consignees about the recalled product the firm asked consignees to take the following actions by May 26, 2021: 1. This notice needs to be passed on to all those within your organization or to any outside organization or customer where the potentially affected product has been transferred. This recall should be carried out to the user level. 2.Review your stock for the affected products and lot numbers and quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. 5. Complete Field Safety Notice Consignee Reconciliation Form (Attachment 1) and return to DJO by May 26, 2021 (see return instructions in Attachment 1) 6. Report any adverse events related to this issue to Customer Service. Your actions above will demonstrate that you have received and understand this notification. Your assistance is appreciated and necessary to prevent the potential health hazards noted above. 7. If you have any questions, please contact Kiersten Soderman at 864-322-3801 or kiersten.soderman@djoglobal.com.
- Quantity
- 10 units
- Distribution
- US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
- Lot, serial or model codes
- Lot # 115T1035
- 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