M/L Taper with Kinectiv Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Us
FDA device recall Z-1699-2015 · posted 2015-06-08 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biological response and subsequent revision
- Action taken
- Zimmer, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated May 18, 2015, to all affected consignees. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate all affected product identified and quarantine them immediately. Carry out a physical count of all affected product in their inventory and complete the Inventory Return Certification Form. Email a completed copy to corporatequality.postmarket@zimmer.com. Return the recalled product along with the completed Inventory return Certification Form. Notify Zimmer of any hospitals that they have further distributed the affected product to. In addition, identify the surgeons that have implanted the product. Supply the information for any hospitals that they have identified, as well as the affected surgeons using the provided spreadsheet template. Customers with questions or concerns should call the customer call center at 1-877-946-2761.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- KWA
- Quantity affected
- 752
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OK, PA, TX, UT, VA, WA, WI and countries of Canada, Australia, Japan, Taiwan, Fr
- Date initiated
- 2015-05-18
- Date posted
- 2015-06-08
- Date terminated
- 2016-08-02
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES (K071856) | Zimmer, Inc. | 2007-07-30 |