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M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues
AUDIENCE: Risk Manager, Surgery, Orthopedics
ISSUE: A process monitoring failure led to higher than expected amounts of manufacturing residues left on the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks. These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant. Manufacturing and distribution dates: March 31, 2015 through April 20, 2015. See Recall Notice for affected lot numbers.
BACKGROUND: The Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks are Tivanium alloy implants used for hip replacements that allow the surgeon to fit the implant specifically to the patient. During hip replacement surgery, the damaged portions of the hip joint are removed and replaced with an integrated system of products, which includes the femoral stem and neck. Recall Initiated on June 8, 2015.
RECOMMENDATION: Review the notification letter Zimmer issued on May 18, 2015 and ensure affected personnel are aware of the contents. Locate all affected product identified in the recall letter and quarantine them immediately. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form sent by the company. Email a completed copy of the form to corporatequality.postmarket@xxxxxxxxxx. Return the recalled product along with the completed Inventory Return Certification Form. Notify Zimmer of any hospitals that you have further distributed the affected product to.
In addition, identify the surgeons that have implanted this product. Supply the information for any hospitals that you have identified, as well as the affected surgeons using the provided spreadsheet template. The template will be emailed to you for completion and return to corporatequality.postmarket@xxxxxxxxxx. Contact the Zimmer customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST with any questions or concerns.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Class I Recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm452012.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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