Femoral Stems and Necks for Hip Implants Recalled Due to Overabundance of Potentially Dangerous Manufacturing Residue

Zimmer, Inc. is recalling its M/L Taper with Kinectiv Technology Femoral Stems and Necks. The firm initiated the recall due to a process monitoring failure that lead to higher than expected amounts of manufacturing residues left on the Tivanium® alloy implants. The U.S. Food and Drug Administration (FDA) gave the recall a Class I classification, which is the agency’s most serious classification.

The M/L Taper with Kinectiv Technology Femoral Stems and Necks are used for hip replacements. The devices allow surgeons to fit the implant specifically to the patient, the FDA explained on the agency’s website. 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.

The higher-than-expected amounts of manufacturing residues can cause serious adverse health issues including allergic reactions, pain, infection or death. Use of the affected M/L Taper with Kinectiv Technology Femoral Stems and Necks may result in the need for revision surgery. This recall applies to devices manufactured and distributed from March 31, 2015 through April 20, 2015.

On May 18, 2015, Zimmer issued recall notification letters and instructions for distributors and hospital staff. The firm instructed distributors to take the following steps:

-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.

Zimmer also instructed hospital staff, including risk managers and surgeons, to do the following:

-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.

Consumers who have questions or concerns should contact Zimmer’s customer call center at 877-946-2761, between 8:00 a.m. and 5:00 p.m., EST.

The full list of recalled M/L Taper with Kinectiv Technology Femoral Stems and Necks including part numbers, lot numbers and item descriptions can be found here.

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