FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
- Recall number
- Z-2658-2017
- Recalling firm
- Encore Medical, Lp
- Product
- 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
- Status
- Terminated
- Initiated
- 2017-05-31
- Posted
- not on file
- Terminated
- 2021-01-08
- Reason
- Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
- Root cause
- Packaging process control
- Action
- The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" dated 5/31/2017 by email to its consignees on 5/31/2017. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following actions by June 16, 2017: pass notice on to all those within the organization or to any organization where the affected product has been transferred; contact customer service at 1-800-456-8696 to place a replacement order and obtain shipment information; return all affected devices; and complete, sign and return the Acknowledgment and Receipt Form by email to: Desiree.Wells@djoglobal.com. The Regulatory Affairs department will follow-up via phone and email with non-responding consignees. If you have any questions, please contact Sr. Director Regulatory Affairs by phone at (760) 734-3551 or by email at Neeta.Sharma@djoglobal.com.
- Quantity
- 9 units
- Distribution
- Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
- Lot, serial or model codes
- Lot # 292G1910
- 510(k) numbers
- ["K091956"]
- 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