Z-1900-2020Class II

Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Name: Z-1900-2020 Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Creator: Howmedica Osteonics Corp.
Published: 2020-04-01
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2020-04-01 / Terminated

FDA source

Howmedica Osteonics Corp. began a recall of Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 on 2020-04-01. FDA classified it as Class II and gives the reason as "Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1900-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-01
Posted: 2020-05-05
Terminated: 2020-08-27
Recalling firm: Howmedica Osteonics Corp
Product: Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Product code: NDN Cement, Bone, Vertebroplasty
Reason for recall: Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
FDA root cause: Storage
Action: On April 1, 2020, the firm distributed Urgent Medical Device Recall letters to all affected customers. Customers were informed that the product had been transported outside of the required refrigerated temperature conditions, which protect the active material components from degradation, and help maintain optimal product set time as well as optimal mechanical properties. Customers were instructed to do the following: NOTE: due to the potential hazards/risks associated with future 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. 2. Immediately check your internal inventory to locate the product listed on the attached business reply form and list the quantity of units on the form. Each form is hospital specific and will include shipment(s) details, including customer P.O. and delivery date. 3. Use the Business Reply Form to reconcile any affected product. Complete the Business Reply Form even if there is no affected product identified. 4. Return the enclosed business reply form by email to [email protected] or fax to 201.575.4675 to confirm receipt of this notification. 5. Upon receipt of the completed Business Reply Form, Stryker will contact you to arrange for the return and replacement of your product(s). 6. After completion of the actions as described above, there are no additional actions that users can and should take to ensure that the product operates safely. - If you desire additional training associated with these instructions, please contact our Regulatory Compliance team at 201.749.8090 or by email at [email protected]. 7. Maintain awareness of this communication internally until all required actions have been completed within your facility. 8. Inform Stryker if any of the subject devices have been distributed to othe
Quantity in commerce: 115
Distribution: US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
Product codes and lots: Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1900-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1900-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)