CLASS II Device recall · Reported 17 Apr 2019 · FDA Enforcement Report
bioBLOCK Resorbable subtaler Implant recalled by Integra
Integra is recalling Integra bioBLOCK Resorbable subtaler Implant, distributed nationwide in the US. The recall was initiated on 1 Mar 2019 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-1089-2019
- FDA event ID
- 82361
- Recalling firm
- Integra, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2019
- FDA classified
- 5 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Surgical Instruments
Timeline
| 1 Mar 2019 | Recall initiated by company | |
| 5 Apr 2019 | Classified by FDA | +35 days |
| 17 Apr 2019 | 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
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
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
Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Where it was distributed
US Nationwide distribution in the states of OH, MI.
Questions about this recall
Is bioBLOCK Resorbable subtaler Implant recalled?
Yes. Integra recalled bioBLOCK Resorbable subtaler Implant on 1 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1089-2019.
Why was it recalled?
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Which lots are affected?
Lot Number:FGD8327
Where was it sold?
US Nationwide distribution in the states of OH, MI.
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.
More recalls from Integra
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Flowable Wound Matrix recalled by Integra | Integra | Potency & Assay | Nationwide |
| Device | CLASS II | bioBLOCK Resorbable subtaler Implant recalled by Integra | Integra | Temperature Abuse | Nationwide |
| Device | CLASS II | bioBLOCK Resorbable subtaler Implant recalled by Integra | Integra | Temperature Abuse | Nationwide |
| Device | CLASS II | Intracranial Pressure and Pressure-Temperature Monitoring recalled | Integra | Sterility | Nationwide |
| Device | CLASS II | Leyla Ball Joint Clamp, also as included recalled by Integra | Integra | Potency & Assay | 23 states |
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| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |