Data Foundry

Medical device recalls 2016

Weck Facial Closure Systems have application in laparoscopic… — Class II medical device recall Z-0759-2017

Terminated recall by Teleflex Medical, reported 2016-12-21, distributed nationwide. The devices wings may become partially detached from the EFx Shield during use.

Recall numberZ-0759-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTeleflex Medical, Research Triangle Park, NC, United States
Recall initiated2016-11-16
Classified2016-12-14
Reported by FDA2016-12-21
Terminated2017-12-13
DistributedNationwide (US)
Countries outside the USBE, CA
Quantity2,265 units
Reason classesdevice malfunction
Lot numbers3264480000, 3269990000, 3270100000

Product

Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Reason for recall

The devices wings may become partially detached from the EFx Shield during use.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0759-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.