CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
U2 Acetabular cup, Ti beads porous coated recalled
Orthopedic Alliance is recalling U2 Acetabular cup, Ti beads porous coated, ¿ U2 Acetabular cup, Ti beads porous coated, 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-1381-2013
- 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
- Hip & Knee Implants
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
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.
Where it was distributed
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Questions about this recall
Is U2 Acetabular cup, Ti beads porous coated, ¿ U2 Acetabular cup, Ti beads porous coated recalled?
Yes. Orthopedic Alliance recalled U2 Acetabular cup, Ti beads porous coated, ¿ U2 Acetabular cup, Ti beads porous coated on 20 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-1381-2013.
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. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm 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 |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |