Z-1090-2019Class II

Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 -

Name: Z-1090-2019 Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 -
Creator: Integra Limited
Published: 2019-03-01
License: https://open.fda.gov/license/

Integra Lifesciences Sales LLC / initiated 2019-03-01 / Terminated / root cause: manufacturing process

FDA source

Integra Limited began a recall of Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary... on 2019-03-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1090-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-01
Posted: 2019-04-05
Terminated: 2020-06-22
Recalling firm: Integra Lifesciences Sales LLC
Product: Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Product code: HWC Screw, Fixation, Bone
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 110F
Root cause tag: manufacturing process
FDA 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 [email protected] .
Quantity in commerce: 232 total
Distribution: US Nationwide distribution in the states of OH, MI.
Product codes and lots: Lot Numbers: FGD2096, FGD8328

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1090-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1089-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-05
Z-1090-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-05
Z-1091-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-05

Product code HWC

K051611Class IIMbaresorb ImplantKinetikos Medical, Inc. / cleared 2005-09-06

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)