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Cortoss recallZ-1900-2020 · Howmedica Osteonics Corp. · initiated Apr 1, 2020

Class II Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Storage

What the company is doing

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

Recall details

Recall number
Z-1900-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 1, 2020
Recalling firm
Howmedica Osteonics Corp.
Quantity
115
Product code
NDN
FDA submissions
K080108
Distribution
US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin

Product description

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

Code information (models, lots, serial numbers)

Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K080108 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page