Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 20, 2017
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 g
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Implant Direct Sybron Manufacturing, LLC recalled Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Gu… - a moderate-severity action.
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Gu… was recalled by Implant Direct Sybron Manufacturing, LLC in September 20, 2017. Reason: The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications re…. Check the official notice for the remedy. Verify recall #Z-3115-2017 with the FDA Devices before acting.
The recall
Implant Direct Sybron Manufacturing, LLC issued this moderate-severity FDA Devices recall-The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications re….
- Moderate
- severity level
- 84 units
- affected scope
- Class II
- classification
- September 20, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3115-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3115-2017) was formally reported on September 20, 2017, with the manufacturer initiating the action on June 26, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Implant Direct Sybron Manufacturing, LLC is listed as the recalling firm, operating out of Westlake Village, CA. Federal records list the affected scope as 84 units.
The documented reason for this recall is: The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
84 units
Related Recalls
6
3 from same agency
Product description
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 for recall
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3115-2017 |
| Date reported | September 20, 2017 |
| Date initiated | June 26, 2017 |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Firm location | Westlake Village, CA |
| Affected scope | 84 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, Netherlands, Spain, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3115-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 84 units.
Why was this product recalled? ▼
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2017. Severity: Moderate. Recall number: Z-3115-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, Netherlands, Spain, Great Britain, Germany and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3115-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 20, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.