| Date Initiated by Firm |
June 22, 2018 |
| Create Date |
August 18, 2018 |
| Recall Status1 |
Terminated 3 on October 09, 2019 |
| Recall Number |
Z-2876-2018 |
| Recall Event ID |
80548 |
| Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
| Product |
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35
Product Usage:
Intended to aid in preparatory surgical procedures
|
| Code Information |
63465803, 63762260, 63767434, 63799794 |
Recalling Firm/
Manufacturer |
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
|
| For Additional Information Contact |
411 Technical Services
574-371-3071
|
Manufacturer Reason
for Recall |
The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.
|
FDA Determined
Cause 2 |
Process control |
| Action |
On June 22, 2018, the firm distributed Urgent Medical Device Recall letters to distributors and hospital risk managers.
Actions for Risk Managers:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
Actions for Distributors:
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.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Include a copy of Attachment 2 Certificate of Sterilization with returned instruments. Mark RECALL on the outside of the returned cartons.
4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall.
b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these |
| Quantity in Commerce |
385 |
| Distribution |
Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands. |
| Total Product Life Cycle |
TPLC Device Report
|
|
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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