Recall Z-0626-2018 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Zimmer Biomet, Inc.
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.
| Date | Aug 25, 2017 |
| Status | Terminated |
| Reason | The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners. |
| Root cause | Mixed-up of materials/components |
| Action | 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 qu |
| Quantity | 8 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS Globus Medical, Inc., Jun 4, 2015 |