Femoral component — Class II medical device recall Z-1378-2013
Terminated recall by Orthopedic Alliance LLC, reported 2013-06-05, distributed nationwide. The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic
| Recall number | Z-1378-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthopedic Alliance LLC, Murrieta, CA, United States |
| Recall initiated | 2013-02-20 |
| Classified | 2013-05-24 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 136 units |
| Model numbers | 2103-1310, 2103-1320, 2103-1330, 2103-1340, 2103-1350, 2103-1360, 2103-1410, 2103-1420, 2103-1430, 2103-1440, 2103-1450, 2103-1460, 2103-3110, 2103-3120, 2103-3130, 2103-3140, 2103-3150, 2103-3160, 2103-3210, 2103-3220, 2103-3230, 2103-3240, 2103-3250, 2103-3260 |
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 component, CR, cemented, #6, left 2103-1360 Femoral component, CR, cemented, #1, right 2103-1410 Femoral component, CR, cemented, #2, right 2103-1420 Femoral component, CR, cemented, #3, right 2103-1430 Femoral component, CR, cemented, #4, right 2103-1440 Femoral component, CR, cemented, #5, right 2103-1450 Femoral component, CR, cemented, #6, right 2103-1460 Femoral component, PS, #1, left 2103-3110 Femoral component, PS, #2, left 2103-3120 Femoral component, PS, #3, left 2103-3130 Femoral component, PS, #4, left 2103-3140 Femoral component, PS, #5, left 2103-3150 Femoral component, PS, #6, left 2103-3160 Femoral component,PS, #1, right 2103-3210 Femoral component,PS, #2, right 2103-3220 Femoral component,PS, #3, right 2103-3230 Femoral component,PS, #4, right 2103-3240 Femoral component,PS, #5, right 2103-3250 Femoral component,PS, #6, right 2103-3260 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1378-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.