A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
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Recall
- Recall Number
- Z-1306-2018
- Event Number
- 79393
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- HRS
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- October 25, 2017
- Terminated
- May 1, 2020
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989
Description
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
The drill guides were manufactured with the incorrect color anodization.
DISTRIBUTORS: Review this notification and ensure that affected team members are aware of the contents. 1. Review this notification and ensure affected team members are aware of the contents. 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 [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. a. Request a Return Authorization Number 5. Return the Additional Accounts form to [email protected] RISK MANAGERS: 1. Review this notification and notify affected personnel of the contents. 2. Assist your Zimmer Biomet sales representative and quarantine all affected product. 3. Complete Certificate of Acknowledgement and send to [email protected].
Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
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