Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 6, 2017
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide fre…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Implant Direct Sybron Manufacturing, LLC recalled ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-p… - a moderate-severity action.
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-p… was recalled by Implant Direct Sybron Manufacturing, LLC in December 6, 2017. Reason: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a porti…. Check the official notice for the remedy. Verify recall #Z-0185-2018 with the FDA Devices before acting.
The recall
Implant Direct Sybron Manufacturing, LLC issued this moderate-severity FDA Devices recall-One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a porti….
- Moderate
- severity level
- 75 units
- affected scope
- Class II
- classification
- December 6, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0185-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0185-2018) was formally reported on December 6, 2017, with the manufacturer initiating the action on October 10, 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 75 units.
The documented reason for this recall is: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the c… Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.. 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 - 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 - 40,422 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
75 units
Related Recalls
6
0 from same agency
Product description
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Reason for recall
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0185-2018 |
| Date reported | December 6, 2017 |
| Date initiated | October 10, 2017 |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Firm location | Westlake Village, CA |
| Affected scope | 75 units |
| Distribution | Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan. |
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-0185-2018) 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? ▼
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 75 units.
Why was this product recalled? ▼
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2017. Severity: Moderate. Recall number: Z-0185-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0185-2018) 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 December 6, 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.