| | Class 2 Device Recall ARCH Leg Positioning System |  |
| Date Initiated by Firm | September 13, 2021 |
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| Create Date | October 07, 2021 |
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| Recall Status1 |
Terminated 3 on January 29, 2024 |
| Recall Number | Z-0072-2022 |
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| Recall Event ID |
88636 |
| Product Classification |
Table and attachments, operating-room - Product Code BWN
|
| Product | ARCH Leg Positioning System |
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| Code Information |
Model: 6813010
Serial Numbers:
6813010.0066;
6813010.0067;
6813010.0069;
6813010.0070;
6813010.0071;
6813010.0072;
6813010.0073;
6813010.0074;
6813010.0075;
6813010.0076; |
| FEI Number |
3006119126
|
Recalling Firm/
Manufacturer |
Innovative Orthopedic Technologies, LLC
1115 Highway 124
Winnie TX 77665
|
| For Additional Information Contact | Suzanne Janacek
409-658-1017 |
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Manufacturer Reason
for Recall | Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. |
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FDA Determined
Cause 2 | Device Design |
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| Action | On 09/13/2021, the firm sent via certified mail an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customers informing them that the Leg Positioning System is being recalled due to a manufacturing defect that may make locking the flexion/extension carriage into position difficult under load.
Customers are instructed to:
1. Contact the Recalling Firm to schedule repair of their device.
2. While customers are waiting for the repair of their device, lifting the boot to lighten the load will pushing the locking pin into place can alleviate the issue.
3. Complete and return the Acknowledgement and Receipt Form to the Recalling Firm by email or mail.
The actions the Recalling Firm is taking:
1. Correcting the issue by temporarily replacing the affected part with an unaffected part while the affected part is being repaired. The repair will be taking place at the Recalling Firm's facility.
2. Implementing an additional functional test that will test the product under load.
For questions and to schedule repair, contact:
Suzanne Janacek, Operations Director - 409-658-1017 Monday through Friday 8:00 AM to 4:30 PM Central Time or email suzanne.janacek@iotiot.com
or mail at 1115 Hwy 124, Winnie, TX 77665 email www.iotiot.com |
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| Quantity in Commerce | 10 units |
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| Distribution | U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.
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| 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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