GemLock Long Hex Driver — Class II medical device recall Z-1115-2015
Terminated recall by Zimmer Dental Inc, reported 2015-02-18. The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the impla
| Recall number | Z-1115-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Dental Inc, Carlsbad, CA, United States |
| Recall initiated | 2015-01-22 |
| Classified | 2015-02-12 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-08-03 |
| Countries outside the US | AE, AR, AU, BG, CA, CL, CO, CR, DE, DO, EC, EG, ES, FR, HK, HU, IL, IR, IT, JP, LB, LT, MA, MX, MY, NL, PA, PK, PL, RO, RS, RU, SA, TH, TN, TR, TW |
| Quantity | 627 units |
| Lot numbers | 62699693, 62728173, 62735177 |
| Model numbers | RHL2.5 |
Product
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.
Reason for recall
The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
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-1115-2015. 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.