—#161382

Product

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.

FDA product code: KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K150552
Affected lot / code info: Item #110024464 Lot# 478340

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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 quality.postmarket@zimmerbiomet.com 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

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2017-08-25
Terminated: 2018-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161382. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.