Data Foundry

Medical device recalls 2013

Integra — Class II medical device recall Z-0886-2013

Terminated recall by Integra LifeSciences Corp., reported 2013-03-06, distributed nationwide. Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained i

Recall numberZ-0886-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntegra LifeSciences Corp., Plainsboro, NJ, United States
Recall initiated2013-02-12
Classified2013-02-26
Reported by FDA2013-03-06
Terminated2013-12-24
DistributedNationwide (US)
Countries outside the USCA
Quantity22,500
Model numbers600-290

Product

Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.

Reason for recall

Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.

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-0886-2013. 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.