FDA Device recall Z-3115-2017
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883
- FDA Device
- Class II
- terminated
- Published 2017-09-20
On 2017-09-20 the FDA classified a Class II recall of Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883 by Implant Direct Sybron Manufacturing, citing the inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3115-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-26 |
| Published | 2017-09-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | US |
Product
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (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 consist 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
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Identifiers
| code_info | Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Implant Direct Sybron Manufacturing recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3115-2017%22
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