Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical… — Class II medical device recall Z-0280-2018
Terminated recall by Zimmer Dental Inc, reported 2017-12-27, distributed nationwide. The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prev
| Recall number | Z-0280-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Dental Inc, Carlsbad, CA, United States |
| Recall initiated | 2017-10-11 |
| Classified | 2017-12-21 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2019-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BG, CA, CL, CR, DE, EG, ES, FR, GB, HK, HU, IE, IL, IR, IT, JP, LB, LT, NI, NL, PL, PT, RO, RS, TH, TN, TR, TW |
| Quantity | 30 kits |
| Lot numbers | 63666559, 63705907 |
Product
Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
Reason for recall
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental 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-0280-2018. 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.