Recall StatusTerminated
Date Initiated2016-12-06
Date Terminated2017-06-08
Reason for Recall
A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Firm Action
Customer notification letters were sent 12/06/16.
Customers were asked to use the criteria of Item Number and Expiration Date to determine if any affected product remains in inventory. Use of the products from the affected item number and expiration date should be discontinued.
Customers are instructed to follow the web link below to complete the Recall Effectiveness Check Form and indicate if any devices with the affected item number and expiration date listed above remain in inventory. ONLINE form must be completed even if no affected product is found.
Use Stryker Sustainability Solutions Ship To Account Number as complete
the form. If do not know your Ship To Account Number, contact local sales
representative or call Stryker Sustainability Solutions Customer Care at 1-888-763-8803 to obtain this number.
If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to facility for all affected devices in scope of this recall that are returned.
Address any questions regarding the recall to Novasyte by calling (760) 279-3126 or
emailing
[email protected].
Adverse reactions or quality problems experienced with the use of this product may be reported to:
- Stryker Sustainability Solutions Complaint Hotline: +1-888-763-8803 http://www.stryker.com/productexperience/
- The FDAs MedWatch Adverse Event Reporting program either online, by
regular mail, or by fax.
Root Cause
Under Investigation by firm
Distribution Pattern
U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT
Foreign distribution to the following: CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.