Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks Higher than Expected Levels of Manufacturing Residues
Recall Class: Class I
Date Recall Initiated: June 8, 2015
Device: Affected lot numbers and item descriptions are listed below.
Manufacturing and distribution dates: March 31, 2015 through April 20, 2015
Use: 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.
Recalling Firm:
Zimmer, Inc.
1800 West Center Street
Warsaw, IN 46580
Reason for Recall: The company found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. 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.
The company has not received any complaints related to this issue for any of the lots in distribution.
Public Contact: Questions or concerns should contact the customer call center at
1-877-946-2761 between 8:00 am and 5:00pm EST.
FDA District: Detroit District Office
More Information about this Recall:
On May 18, 2015, Zimmer issued recall notification letters and instructions for distributors and hospital staff.
Instructions for distributors:
- Review the notification 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@zimmer.com.
- Return the recalled product along with the completed Inventory Return Certification Form.
- Please 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@zimmer.com.
Instructions for hospital staff, including risk managers and surgeons:
- Review the notification and ensure affected personnel are aware of the contents.
- Assist your Zimmer sales representative with the quarantine of any affected product.
- Your Zimmer sales representative will remove the recalled product from your facility.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
