FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp. d.b.a. Integra Pain Management: Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
- Recall number
- Z-2733-2016
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Product
- Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
- Status
- Terminated
- Initiated
- 2016-08-24
- Posted
- 2016-09-02
- Terminated
- 2017-03-30
- Reason
- 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.
- Root cause
- Packaging
- Action
- Consignees notified on August 12, 2016 via letter to identify and return product.
- Quantity
- 710
- Distribution
- Nationwide and VA/govt/military. No foreign consignees.
- Lot, serial or model codes
- Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12
- 510(k) numbers
- ["K961113"]
- PMA numbers
- not on file
- Product code
- HBG
- Firm FEI
- 1000138491
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28