PRO-STIM 10cc INJECTABLE — Class II medical device recall Z-0564-2020
Terminated recall by Wright Medical Technology, Inc., reported 2019-12-04. The firm discovered a lack of adequate documentation confirming sterility on certain products.
| Recall number | Z-0564-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wright Medical Technology, Inc., Arlington, TN, United States |
| Recall initiated | 2016-11-08 |
| Classified | 2019-11-25 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2020-11-03 |
| Countries outside the US | AT, BE, CA, CH, DE, DK, ES, FR, GB, IT, JP, NL, NO, TR, TW, ZA |
| Quantity | 19 units |
| Reason classes | sterility |
| Lot numbers | 1564697 |
| Model numbers | 86SR0410 |
Product
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Reason for recall
The firm discovered a lack of adequate documentation confirming sterility on certain products.
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-0564-2020. 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.