FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
- Recall number
- Z-1213-2013
- Recalling firm
- Encore Medical, Lp
- Product
- 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
- Status
- Terminated
- Initiated
- 2013-04-01
- Posted
- 2013-05-02
- Terminated
- 2013-07-01
- Reason
- U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
- Root cause
- Labeling mix-ups
- Action
- The firm sent their US customer a "Urgent Field Safety Notice" letter on April 1, 2013. The letter explained the product problem and provided recommended actions as well as customer contact numbers.
- Quantity
- 5
- Distribution
- US Distribution to the state of California and International Distribution to the country of Venezuela.
- Lot, serial or model codes
- Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
- 510(k) numbers
- ["K091956"]
- PMA numbers
- not on file
- Product code
- OIY
- 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