CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Integra Cranial Access Kits recalled by Integra LifeSciences Corp.
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling Integra Cranial Access Kits, distributed nationwide in the US. The recall was initiated on 24 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2733-2016
- FDA event ID
- 75028
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2016
- FDA classified
- 2 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 24 Aug 2016 | Recall initiated by company | |
| 2 Sep 2016 | Classified by FDA | +9 days |
| 14 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Where it was distributed
Nationwide and VA/govt/military. No foreign consignees.
Questions about this recall
Is Integra Cranial Access Kits recalled?
Yes. Integra LifeSciences Corp. d.b.a. Integra Pain Management recalled Integra Cranial Access Kits on 24 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-2733-2016.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Nationwide and VA/govt/military. No foreign consignees.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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