CLASS II Device recall · Reported 5 Mar 2014 · FDA Enforcement Report
Specialty Straight Static Inserter Assembly recalled by Stryker Spine
Stryker Spine is recalling Specialty Straight Static Inserter Assembly, distributed nationwide in the US. The recall was initiated on 18 Dec 2013 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-1086-2014
- FDA event ID
- 67388
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2013
- FDA classified
- 24 Feb 2014
- Reported
- 5 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 18 Dec 2013 | Recall initiated by company | |
| 24 Feb 2014 | Classified by FDA | +68 days |
| 5 Mar 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Product as listed by the FDA
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Which lots are affected?
D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242
Where was it sold?
US Nationwide Distribution
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stryker Spine
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|---|---|---|---|---|---|
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
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