FDA (Devices) recall action 64588

Orthopedic Alliance LLC recalled 9 products on 2013-06-05

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2013-06-05
Critical: 0
Units: 821

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

ModerateFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 50 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.
Product
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-Standa
Category
Distribution
5 states
LowFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues
Orthopedic Alliance LLC is recalling 30 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
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 po
Category
Distribution
5 states
ModerateFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays
Orthopedic Alliance LLC is recalling 57 units of loaner bins and sterilization trays because surgical instructions were not provided to every physician.
Product
UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE
Category
Distribution
5 states
ModerateFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Bipolar Caps Due to Missing Surgical Instructions
Orthopedic Alliance LLC is recalling 37 Bipolar Caps because directions for use and surgical techniques were not provided to every physician for every surgery.
Product
Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm
Category
Distribution
5 states
ModerateFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants and instruments because directions for use and surgical techniques were not provided to every physician for every surgery.
Product
Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303
Category
Distribution
5 states
ModerateFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 26 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.
Product
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 B
Category
Distribution
5 states
ModerateFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.
Product
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
Category
Distribution
5 states
ModerateFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 21 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
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 Femora
Category
Distribution
5 states
ModerateFDA (Devices)··2013-06-05
Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.
Product
Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral compone
Category
Distribution
5 states