FDA Medical Device Recalls (openFDA)
Integra Limited: 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.
- Recall number
- Z-1089-2019
- Recalling firm
- Integra Limited
- Product
- 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.
- Status
- Terminated
- Initiated
- 2019-03-01
- Posted
- not on file
- Terminated
- 2020-06-22
- Reason
- 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 110F
- Root cause
- Process control
- Action
- Integra LifeSciences Corp. notified consignees (Hospitals and Distributors) by letter delivered by courier service, facsimile or email about the initial notification on March 1st, 2019.Letter explains problem, health risk and action to take: examine inventory to determine if you have any affected lots with discolored temperature dots, where the dots look similar as pictures labeled UNACCEPTABLE on previous page.. If you do have any product with discolored temperature dots, stop using the product immediately, remove them from service and place in quarantine until the product can be returned. Complete the attached Acknowledgement and Return Form. Questions Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM 8:00 PM EST or custsvcnj@integralife.com .
- Quantity
- 232 total
- Distribution
- US Nationwide distribution in the states of OH, MI.
- Lot, serial or model codes
- Lot Number:FGD8327
- 510(k) numbers
- ["K051611"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3001700044
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28