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FDA-Device2013-06-05Class II

U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads porous coated, ¿54mm U2 Acetabular cup, Ti beads porous coated, ¿56mm U2 Acetabular cup, Ti beads porous coated, ¿58mm U2 Acetabular cup, Ti beads porous coated, ¿60mm U2 Acetabular cup, Ti beads porous coated, ¿62mm

Orthopedic Alliance LLC
Hazard

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.

Sold states
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Affected count
30 units
Manufactured in
26157 Jefferson Ave, N/A, Murrieta, CA, United States
Products
U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads porous coated, ¿54mm U2 Acetabular cup, Ti beads porous coated, ¿56mm U2 Acetabular cup, Ti beads porous coated, ¿58mm U2 Acetabular cup, Ti beads porous coated, ¿60mm U2 Acetabular cup, Ti beads porous coated, ¿62mm U2 Acetabular cup liner assembly, 10¿hooded,44mm U2 Acetabular cup liner assembly, 10¿hooded,46mm U2 Acetabular cup liner assembly, 10¿hooded,48mm U2 Acetabular cup liner assembly, 10¿hooded,50mm U2 Acetabular cup liner assembly, 10¿hooded,52mm U2 Acetabular cup liner assembly, 10¿hooded,54mm U2 Acetabular cup liner assembly, 10¿hooded,56mm U2 Acetabular cup liner assembly, 10¿hooded,58mm U2 Acetabular cup liner assembly, 10¿hooded,60mm U2 Acetabular cup liner assembly, 10¿hooded,62mm Variety of hip and knee implants and instruments, multiple uses.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2013

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