G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.
Recall
- Recall Number
- Z-0626-2018
- Event Number
- 79104
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- KWY
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- August 25, 2017
- Terminated
- August 16, 2018
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989
Description
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.
The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
On August 30, 2017 an Urgent medical device recall removal notice was mailed to customers identified as "G7 Dual Mobility Liner". The recall letter requests the following actions to be taken: 1. Review this notification and ensure affected team members are aware of the contents. CF04107 Rev. 2, Eff. Date: 21 Feb. 2017 Ref. CP04102 Recall Activities Page 2 of 4 ZFA 2017-347 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to corporate [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. Questions or concerns can be directed to Customer Service at 1-574-371-3071
US Nationwide Distribution
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