Home / Recalls / Orthopedic Alliance LLC / Z-1386-2013

Z-1386-2013 Class II Terminated

Recalled by Orthopedic Alliance LLC — Murrieta, CA

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
26 units

Product Description

Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long

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. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32

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-1379-2013 Class II — Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 (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-1385-2013 Class II — Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz (February 20, 2013)
  • Z-1383-2013 Class II — Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, O (February 20, 2013)
  • Z-1380-2013 Class II — UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,lar (February 20, 2013)