Integra Cranial Access Kits — Class II medical device recall Z-2733-2016
Terminated recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, reported 2016-09-14, distributed nationwide. Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Ri
| Recall number | Z-2733-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT, United States |
| Recall initiated | 2016-08-24 |
| Classified | 2016-09-02 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 710 |
| Lot numbers | 2016-11, 2016-12, W1605101, W1605103, W1605106, W1606063 |
Product
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Reason for recall
Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.
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-2733-2016. 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.