CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm recalled
Orthopedic Alliance is recalling Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm, distributed nationwide in the US. The recall was initiated on 20 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1383-2013
- FDA event ID
- 64588
- Recalling firm
- Orthopedic Alliance, Murrieta, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2013
- FDA classified
- 24 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 20 Feb 2013 | Recall initiated by company | |
| 24 May 2013 | Classified by FDA | +93 days |
| 5 Jun 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Questions about this recall
Why was it 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.
Which lots are affected?
Item No. 1503-3042 1503-3144 1503-3146 1503-3148 1503-3150 1503-3152 1503-3154 1503-3156
Where was it sold?
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 64588This product is part of a recall event; the main page for the event is Uknee Patella,small 2401-1010 Uknee Patella,medium recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Uknee Patella,small 2401-1010 Uknee Patella,medium recalled | Orthopedic Alliance | Sterility | Nationwide | |
| CLASS II | Tibial baseplate,cemented,#1 2203-3010 Tibial recalled | Orthopedic Alliance | Sterility | Nationwide | |
| CLASS II | U2 Acetabular cup, Ti beads porous coated recalled | Orthopedic Alliance | Sterility | Nationwide | |
| CLASS II | Zweimueller Type Stem Scs-Standard Sz 01 Zweimueller Type recalled | Orthopedic Alliance | Sterility | Nationwide | |
| CLASS II | Ball Head, 28 Short Ceramic Ball Head recalled by Orthopedic Alliance | Orthopedic Alliance | Sterility | Nationwide | |
| CLASS II | Co-Cr cancellous bone screw Co-Cr cancellous bone screw recalled | Orthopedic Alliance | Sterility | Nationwide | |
| CLASS II | Femoral head, standard, ¿, + Femoral head,medium recalled | Orthopedic Alliance | Sterility | Nationwide | |
| CLASS II | Femoral component, CR, cemented, #1 recalled by Orthopedic Alliance | Orthopedic Alliance | Sterility | Nationwide |
More recalls from Orthopedic Alliance
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Femoral component, CR, cemented, #1 recalled by Orthopedic Alliance | Orthopedic Alliance | Sterility | Nationwide |
| Device | CLASS II | Femoral head, standard, ¿, + Femoral head,medium recalled | Orthopedic Alliance | Sterility | Nationwide |
| Device | CLASS II | Co-Cr cancellous bone screw Co-Cr cancellous bone screw recalled | Orthopedic Alliance | Sterility | Nationwide |
| Device | CLASS II | Ball Head, 28 Short Ceramic Ball Head recalled by Orthopedic Alliance | Orthopedic Alliance | Sterility | Nationwide |
| Device | CLASS II | Zweimueller Type Stem Scs-Standard Sz 01 Zweimueller Type recalled | Orthopedic Alliance | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |