Date Initiated by Firm | February 25, 2020 |
Create Date | March 31, 2020 |
Recall Status1 |
Terminated 3 on August 05, 2020 |
Recall Number | Z-1615-2020 |
Recall Event ID |
85143 |
510(K)Number | K120121 |
Product Classification |
shoulder prosthesis, reverse configuration - Product Code PHX
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Product | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency
Item Number: 010000589 |
Code Information |
Lot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer Reason for Recall | Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters. |
FDA Determined Cause 2 | Packaging process control |
Action | Zimmer Biomet issued notification letter on 2/25/20 via email to the International consignees states reason for recall, health risk and action to take:
Hospital Responsibilities
1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certification of Acknowledgement Form and send to fieldaction.emea@zimmerbiomet.com.This form must be returned even if you do not have affected products available to return in your facility. 5. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facilitys documentation.
6. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative. |
Quantity in Commerce | 21 units |
Distribution | International distribution - country of Netherland.s |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = PHX
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