ImplantDirect InterActive Precision IO Scan Adapter — Class II medical device recall Z-0790-2020
Completed recall by Implant Direct Sybron Manufacturing, LLC, reported 2020-01-15, distributed in AL, AZ, CA, FL, GA, KS, MA, MD…. The peek part was loose on the titanium base of the device which could result in it falling into a patient's m
| Recall number | Z-0790-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks, CA, United States |
| Recall initiated | 2018-11-28 |
| Classified | 2020-01-08 |
| Reported by FDA | 2020-01-15 |
| Distributed | AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA |
| Countries outside the US | AU, CA, CH, DE, DK, ES, FR, GB, IS, IT, LT, NL, PL, SE |
| Quantity | 274 devices |
| Lot numbers | 104479, 104963 |
| Model numbers | 6534-09PT |
Product
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason for recall
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
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-0790-2020. 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.