Z-2100-2021Class II

Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962

Name: Z-2100-2021 Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Creator: Stryker Spine
Published: 2021-05-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2021-05-18 / Terminated

FDA source

Stryker Spine began a recall of Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962 on 2021-05-18. FDA classified it as Class II and gives the reason as "The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2100-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-18
Posted: 2021-07-20
Terminated: 2022-04-15
Recalling firm: Howmedica Osteonics Corp
Product: Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Product code: NDN Cement, Bone, Vertebroplasty
Reason for recall: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
FDA root cause: Storage
Action: Urgent Medical Device Recall notification letters dated 5/14/21 were sent to customers. Actions needed NOTE: due to the potential hazards/risks associated with use of product associated with these shipments, please urgently quarantine the in-scope product. 1. Immediately review the Product Recall Notification. Please forward this information to all appropriate personnel within your organization. Maintain awareness of this communication internally until all required actions have been completed within your facility. 2. Immediately check your internal inventory to locate the affected products. Quarantine and discontinue use of any affected Cortoss Bone Augmentation Material. Your local Stryker Representative is available to assist with removal of this product. 3. Complete the enclosed business reply form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please return the BRF, even if you dont have any affected product on hand, via email to [email protected]. 4. Upon receipt of the completed BRF, replacement(s) will be shipped to your facility. 5. If you have further distributed this product to other organizations, please provide contact details on the BRF so that Stryker can inform the recipients appropriately. If you have any questions or concerns, please contact Regulatory Compliance at 201-749-8090.
Quantity in commerce: 559 total
Distribution: US Nationwide Distribution
Product codes and lots: lot A1908003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2100-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-20
Z-2101-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-20

Product code NDN

K080108Class IICortoss Bone Augmentation MaterialOrthovita, Inc. / cleared 2009-06-05

MDM coverage of this record lists here, newest first.

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)