IMPLANT — Class II medical device recall Z-0784-2016
Terminated recall by Zimmer Dental Inc, reported 2016-02-17, distributed nationwide. Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the l
| Recall number | Z-0784-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Dental Inc, Carlsbad, CA, United States |
| Recall initiated | 2016-01-06 |
| Classified | 2016-02-08 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO, DE, ES, FR, HU, IT, NL, PL, SA, TH |
| Quantity | 1,059 |
| Lot numbers | 63192173 |
| Model numbers | TMTB16 |
Product
IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Reason for recall
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
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-0784-2016. 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.