Severity
Moderate
FDA Devices recall · Reported December 21, 2016
The devices wings may become partially detached from the EFx Shield during use.
Teleflex Medical recalled Weck Facial Closure Systems have application in laparoscopic procedures for approximatio… - a moderate-severity action.
Weck Facial Closure Systems have application in laparoscopic procedures for approximatio… was recalled by Teleflex Medical in December 21, 2016. Reason: The devices wings may become partially detached from the EFx Shield during use.. Check the official notice for the remedy. Verify recall #Z-0759-2017 with the FDA Devices before acting.
The recall
Teleflex Medical issued this moderate-severity FDA Devices recall-The devices wings may become partially detached from the EFx Shield during use..
Sourced from official FDA Devices enforcement records. Verify recall #Z-0759-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0759-2017) was formally reported on December 21, 2016, with the manufacturer initiating the action on November 16, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Research Triangle Park, NC. Federal records list the affected scope as 2265 units.
The documented reason for this recall is: The devices wings may become partially detached from the EFx Shield during use. Distribution data in the federal record shows the product reached: Domestic; US Nationwide; International: Belgium, 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.
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.
Severity
Moderate
Affected scope
2265 units
Related Recalls
6
3 from same agency
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
The devices wings may become partially detached from the EFx Shield during use.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0759-2017 |
| Date reported | December 21, 2016 |
| Date initiated | November 16, 2016 |
| Recalling firm | Teleflex Medical |
| Firm location | Research Triangle Park, NC |
| Affected scope | 2265 units |
| Distribution | Domestic; US Nationwide; International: Belgium, Canada. |
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.
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.
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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 21, 2016. 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.