Spectra System/Legacy Guided Surgery Handle Kit — Class II medical device recall Z-0283-2018
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2017-12-27, distributed nationwide. The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct
| Recall number | Z-0283-2018 |
|---|---|
| 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 | 2017-11-15 |
| Classified | 2017-12-21 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2018-10-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, EG, JO, LB |
| Quantity | 560 units |
| Lot numbers | 38665, 38825, 42562, 42649, 43810, 45014, 45018, 46950, 50165, 52360, 52987, 60376, 62435, 64245, 67044, 70293, 73431, 73729, 74772 |
Product
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
Reason for recall
The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large.
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-0283-2018. 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.