PrimaConnex Tapered Implant TC — Class II medical device recall Z-0973-2013
Terminated recall by Keystone Dental Inc, reported 2013-03-27, distributed in CA, DC, FL, IN, MA, MN, NH, NJ…. Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
| Recall number | Z-0973-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2013-03-11 |
| Classified | 2013-03-20 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-09-26 |
| Distributed | CA, DC, FL, IN, MA, MN, NH, NJ, NY, PA, WI |
| Countries outside the US | CN, DE, FR |
| Quantity | 120 units |
| Reason classes | labeling |
| Lot numbers | 12857 |
| Model numbers | L5613K |
Product
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Reason for recall
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
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-0973-2013. 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.