SwishTapered Implant — Class II medical device recall Z-1112-2017
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2017-02-08, distributed in CA, ME, NM, OH, OR, TX. The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 732
| Recall number | Z-1112-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA, United States |
| Recall initiated | 2016-12-12 |
| Classified | 2017-01-28 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-05-22 |
| Distributed | CA, ME, NM, OH, OR, TX |
| Countries outside the US | NL |
| Quantity | 17 |
| Reason classes | packaging |
| Lot numbers | 73241 |
Product
SwishTapered Implant
Reason for recall
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
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-1112-2017. 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.