ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable… — Class II medical device recall Z-1912-2014
Terminated recall by The Anspach Effort, Inc., reported 2014-07-02, distributed in AL, CA, FL, IA, IL, KY, MN, MS…. The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were n
| Recall number | Z-1912-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2012-11-28 |
| Classified | 2014-06-25 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2014-08-07 |
| Distributed | AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX |
| Countries outside the US | CA, HU, JP, KR, SE |
| Quantity | 40 |
| Serial numbers | 200095, 200279, 200280, 200281 |
| Model numbers | SP-4603-00 |
Product
ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Reason for recall
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
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-1912-2014. 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.