Recall Z-2418-2019

Reason for recall

The seal integrity of the sterile bag containing the kits may be compromised.

FDA-determined cause: Packaging

Action taken

The firm, Stryker, sent an "UPDATE URGENT MEDICAL DEVICE RECALL" notification letters dated 7/25/19 were to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-855-207-2792 or email to Strykerortho6807@stericycle.com 5. Hospitals/Branches/Agencies: Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns (Ref# PFA 2042684) Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. If you have any questions, please contact Director Post Market Compliance and Quality System at 201-831-5151 or Stan.dube@stryker.com; your local Sales Office or the Stryker Sales Representative for assistance.