Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 19, 2020
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Implant Direct Sybron Manufacturing LLC recalled SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 - a moderate-severity action.
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 was recalled by Implant Direct Sybron Manufacturing LLC in February 19, 2020. Reason: Due to a complaint received and internal investigation it was determined that implant vials were distributed …. Check the official notice for the remedy. Verify recall #Z-1126-2020 with the FDA Devices before acting.
The recall
Implant Direct Sybron Manufacturing LLC issued this moderate-severity FDA Devices recall-Due to a complaint received and internal investigation it was determined that implant vials were distributed ….
- Moderate
- severity level
- 11 units
- affected scope
- Class II
- classification
- February 19, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1126-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1126-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on January 9, 2019. 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 11 units.
The documented reason for this recall is: Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the produ… Distribution data in the federal record shows the product reached: US: None OUS: Iceland, Sweden, Spain,. 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
11 units
Related Recalls
6
3 from same agency
Product description
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Reason for recall
Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1126-2020 |
| Date reported | February 19, 2020 |
| Date initiated | January 9, 2019 |
| Recalling firm | Implant Direct Sybron Manufacturing LLC |
| Firm location | Westlake Village, CA |
| Affected scope | 11 units |
| Distribution | US: None OUS: Iceland, Sweden, 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-1126-2020) 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? ▼
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708. Recalled by Implant Direct Sybron Manufacturing LLC. Units affected: 11 units.
Why was this product recalled? ▼
Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1126-2020.
Where was the recalled product distributed? ▼
Distribution: US: None OUS: Iceland, Sweden, Spain,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1126-2020) 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 February 19, 2020. 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.