Mac Pin Non-Cannulated Screw — Class II medical device recall Z-0325-2018
Terminated recall by Amendia, Inc, reported 2018-01-17, distributed in GA. Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 m
| Recall number | Z-0325-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc, Marietta, GA, United States |
| Recall initiated | 2017-07-07 |
| Classified | 2018-01-10 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2019-10-15 |
| Distributed | GA |
| Quantity | 41 screws |
| Reason classes | labeling |
| Lot numbers | 132117 |
| Model numbers | 85-6560-1 |
Product
Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Reason for recall
Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
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-0325-2018. 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.