Ball Head — Class II medical device recall Z-1386-2013
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-1386-2013 |
|---|---|
| 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 | 26 units |
| Model numbers | 188.01.28, 188.02.28, 188.03.28, 188.04.28, 188.05.28, 189.01.32, 189.02.32, 189.03.32, 194.01.28, 194.02.28, 194.03.28, 195.01.32, 195.02.32, 195.03.32 |
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 Ball Head, 28 XX-Long CoCr Ball Head, 32 Short Ball Head, 32 Medium Ball Head, 32 Long
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-1386-2013. 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.