Home / Recalls / Orthopedic Alliance LLC / Z-1385-2013

Z-1385-2013 Class II Terminated

Recalled by Orthopedic Alliance LLC — Murrieta, CA

FDA device recall Z-1385-2013 was initiated by Orthopedic Alliance LLC on February 20, 2013 and is designated Class II. Reason for recall: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to… The recall status is terminated (terminated March 26, 2014). Affected quantity: 50 units.

Recall Details

Product Type: Devices
Report Date: June 5, 2013
Initiation Date: February 20, 2013
Termination Date: March 26, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 50 units

Product Description

Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standard Sz 5 Zweimueller Type Stem SCS-Standard Sz 6 Zweimueller Type Stem SCS-Standard Sz 7 Zweimueller Type Stem SCS-Standard Sz 8 Zweimueller Type Stem SCS-Standard Sz 9 Zweimueller Type Stem SCS-Standard Sz 10 Zweimueller Type Stem SCL-Lateralized Sz 3 Zweimueller Type Stem SCL-Lateralized Sz 4 Zweimueller Type Stem SCL-Lateralized Sz 5 Zweimueller Type Stem SCL-Lateralized Sz 6 Zweimueller Type Stem SCL-Lateralized Sz 7 Zweimueller Type Stem SCL-Lateralized Sz 8 Zweimueller Type Stem SCL-Lateralized Sz 9 Zweimueller Type Stem SCR-Revision Sz 3 Zweimueller Type Stem SCR-Revision Sz 4 Zweimueller Type Stem SCR-Revision Sz 5 Zweimueller Type Stem SCR-Revision Sz 6 Zweimueller Type Stem SCR-Revision Sz 7 Zweimueller Type Stem SCR-Revision Sz 8 Zweimueller Type Stem SCR-Revision Sz 9 Zweimueller Type Stem SCR-Revision Sz 10 Zweimueller Type Stem SCR-Revision Sz 11 Variety of hip and knee implants and instruments, multiple uses.

Reason for Recall

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Distribution Pattern

Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

Code Information

Part No. 120.00.15 120.00.00 120.00.01 120.00.02 120.00.03 120.00.04 120.00.05 120.00.06 120.00.07 120.00.08 120.00.09 120.00.10 123.00.03 123.00.04 123.00.05 123.00.06 123.00.07 123.00.08 123.00.09 126.00.03 126.00.04 126.00.05 126.00.06 126.00.07 126.00.08 126.00.09 126.00.10 126.00.11

Other recalls by Orthopedic Alliance LLC

Z-1156-2013 Class II — Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC30 (March 7, 2013)
Z-1382-2013 Class II — Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral he (February 20, 2013)
Z-1378-2013 Class II — Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, ceme (February 20, 2013)
Z-1384-2013 Class II — Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancel (February 20, 2013)
Z-1383-2013 Class II — Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, O (February 20, 2013)
Z-1381-2013 Class II — U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads po (February 20, 2013)
Z-1379-2013 Class II — Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 (February 20, 2013)
Z-1386-2013 Class II — Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CE (February 20, 2013)
Z-1380-2013 Class II — UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,lar (February 20, 2013)