Medical Devices

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:

  1. Review the notification and ensure affected personnel are aware of the contents.
  2. Locate all affected product identified in the recall letter and quarantine them immediately.
  3. 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.
  4. Return the recalled product along with the completed Inventory Return Certification Form.
  5. 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:

  1. Review the notification and ensure affected personnel are aware of the contents.
     
  2. Assist your Zimmer sales representative with the quarantine of any affected product.
  3. 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.

Products Being Recalled:

Part NumberLot NumberItem Description
0077130130062885058MOD ML TAPER FEM ST 13.5
0077130110062885040MOD ML TAPER FEM ST 11
6577130110062939041MOD ML TAPER FEM ST 11 HATCP
0077130100062938997MOD ML TAPER FEM ST 10
0077130050063006851MOD ML TAPER FEM ST 5
0077130090062927082MOD ML TAPER FEM ST 9.0
0077130050063006852MOD ML TAPER FEM ST 5
0077130110062905574MOD ML TAPER FEM ST 11
0077130060063024189MOD ML TAPER FEM ST 6
0077130110062998426MOD ML TAPER FEM ST 11
0077130110063024240MOD ML TAPER FEM ST 11
0077130090063024220MOD ML TAPER FEM ST 9.0
0077130070063024204MOD ML TAPER FEM ST 7.5
0077130100063024229MOD ML TAPER FEM ST 10
0077130100063024230MOD ML TAPER FEM ST 10
0077130110063024239MOD ML TAPER FEM ST 11
0077130070063024205MOD ML TAPER FEM ST 7.5
0077130070063024206MOD ML TAPER FEM ST 7.5
0077130110063024241MOD ML TAPER FEM ST 11
0077130090063024219MOD ML TAPER FEM ST 9.0
0077130120063024262MOD ML TAPER FEM ST 12.5
0077130110063024238MOD ML TAPER FEM ST 11
0077130130063024245MOD ML TAPER FEM ST 13.5
0077130110063024237MOD ML TAPER FEM ST 11
0077130070063024201MOD ML TAPER FEM ST 7.5
0077130100063024228MOD ML TAPER FEM ST 10
0077130090063024218MOD ML TAPER FEM ST 9.0
0077130060063024187MOD ML TAPER FEM ST 6
0077130090063024217MOD ML TAPER FEM ST 9.0
0077130120063024263MOD ML TAPER FEM ST 12.5
0077130090063024221MOD ML TAPER FEM ST 9.0
0077130120063024261MOD ML TAPER FEM ST 12.5
0077130070063024203MOD ML TAPER FEM ST 7.5
0077130120062927123MOD ML TAPER FEM ST 12.5
0077130090062927083MOD ML TAPER FEM ST 9.0
0077130090063024216MOD ML TAPER FEM ST 9.0
0077130060063024188MOD ML TAPER FEM ST 6
0077130070063024202MOD ML TAPER FEM ST 7.5
0077130060063024184MOD ML TAPER FEM ST 6
0077130110063024234MOD ML TAPER FEM ST 11
0077130090063024210MOD ML TAPER FEM ST 9.0
0077130070063024195MOD ML TAPER FEM ST 7.5
0077130070063024196MOD ML TAPER FEM ST 7.5
0078480140062924878KINECTIV MODULAR NECK X
0077130090063024211MOD ML TAPER FEM ST 9.0
0077130100063024226MOD ML TAPER FEM ST 10
0077130070063024197MOD ML TAPER FEM ST 7.5
0077130060063024186MOD ML TAPER FEM ST 6
0077130070063024198MOD ML TAPER FEM ST 7.5
0077130070063024199MOD ML TAPER FEM ST 7.5
0077130120063024258MOD ML TAPER FEM ST 12.5
0077130090063024214MOD ML TAPER FEM ST 9.0
0077130120063024256MOD ML TAPER FEM ST 12.5
0077130100063024227MOD ML TAPER FEM ST 10
0077130090063024213MOD ML TAPER FEM ST 9.0
0077130120063024259MOD ML TAPER FEM ST 12.5
0077130110063024236MOD ML TAPER FEM ST 11
0077130090063024215MOD ML TAPER FEM ST 9.0
0077130110063024235MOD ML TAPER FEM ST 11
0077130120063024257MOD ML TAPER FEM ST 12.5
0077130050063024180MOD ML TAPER FEM ST 5
0077130060063024183MOD ML TAPER FEM ST 6
0077130130062939008MOD ML TAPER FEM ST 13.5
0077130070063024193MOD ML TAPER FEM ST 7.5

Page Last Updated: 06/19/2015
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