Paltop 1 — Class II medical device recall Z-1064-2019
Terminated recall by Keystone Dental Inc, reported 2019-04-03, distributed in FL, MA, SC, VA. Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, mak
| Recall number | Z-1064-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2019-02-22 |
| Classified | 2019-03-27 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-06-19 |
| Distributed | FL, MA, SC, VA |
| Quantity | 3 hex |
| Lot numbers | WO-010354 |
| Model numbers | 60-70102 |
Product
Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
Reason for recall
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
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-1064-2019. 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.