CLASS II Device recall · Reported 28 Jul 2021 · FDA Enforcement Report
Cortoss Bone Augmentation Material 5cc Cartridge recalled
Stryker Spine is recalling Cortoss Bone Augmentation Material 5cc Cartridge, distributed nationwide in the US. The recall was initiated on 18 May 2021 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-2100-2021
- FDA event ID
- 88217
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2021
- FDA classified
- 20 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 18 May 2021 | Recall initiated by company | |
| 20 Jul 2021 | Classified by FDA | +63 days |
| 28 Jul 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Which lots are affected?
lot A1908003
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.
Other products in this recall event
1 other product · FDA event 88217| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cortoss Bone Augmentation Material 10cc Cartridge recalled | Stryker Spine | Temperature Abuse | Nationwide |
More recalls from Stryker Spine
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | AVS Anchor-C Cervical Cage System Instructions For Use recalled | Stryker Spine | Other | Nationwide |
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