Integra — Class II medical device recall Z-2028-2012
Terminated recall by Integra Limited, reported 2012-07-25, distributed nationwide. The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out o
| Recall number | Z-2028-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra Limited, Plainsboro, NJ, United States |
| Recall initiated | 2012-05-23 |
| Classified | 2012-07-18 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 108 |
| Reason classes | specification failure |
| Lot numbers | 1045872, 1045873, 1045874, 1045875, 1045876, 1045877, 1045878, 1045879, 1045880, 1045881, 1045882, 1045884, 1045885, 1045886, 1045887, 1045888, 1045889, 1045890, 1045891, 1045892, 1045893, 1045894, 1045895 |
| Model numbers | 643350, 643425, 643650, 643725 |
Product
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.
Reason for recall
The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
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-2028-2012. 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.