Recall Z-1382-2013— Orthopedic Alliance LLC

Name: FDA recall Z-1382-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-20

Class II · Terminated

Class II FDA medical device recall by Orthopedic Alliance LLC, initiated 2013-02-20, terminated 2014-03-26. It names one FDA 510(k) clearance: K111546. Product: Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm Femoral head, ¿32mm, +0mm Femoral head, ¿32mm, +5mm Femoral head, ¿32mm, +10mm Femoral head, ¿36mm, -3mm Femoral head, ¿36mm, +0mm Femoral head, ¿36mm, +5mm Femoral head, ¿36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.. Reason: 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..

Recalling firm: Orthopedic Alliance LLC
Classification: Class II
Status: Terminated
Initiated: 2013-02-20
Terminated: 2014-03-26
Firm location: Murrieta, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K111546 — U2 HIP SYSTEMUnited Orthopedic Corp.·cleared 2011-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm Femoral head, ¿32mm, +0mm Femoral head, ¿32mm, +5mm Femoral head, ¿32mm, +10mm Femoral head, ¿36mm, -3mm Femoral head, ¿36mm, +0mm Femoral head, ¿36mm, +5mm Femoral head, ¿36mm, +10mm 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.