Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
FDA device recall Z-2733-2016 · posted 2016-09-02 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- 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.
- Action taken
- Consignees notified on August 12, 2016 via letter to identify and return product.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HBG
- Quantity affected
- 710
- Distribution
- Nationwide and VA/govt/military. No foreign consignees.
- Date initiated
- 2016-08-24
- Date posted
- 2016-09-02
- Date terminated
- 2017-03-30
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113) | Clinical Neuro Systems, LLC | 1996-06-05 |