Date Initiated by Firm | September 12, 2022 |
Date Posted | November 22, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0277-2023 |
Recall Event ID |
91098 |
510(K)Number | K151881 |
Product Classification |
Software for diagnosis/treatment - Product Code OSN
|
Product | Orthex Large Bone Shoulder Bolt, model no. AS-17 |
Code Information |
UDI-DI: 00841132143155
Lots:
921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E
|
Recalling Firm/ Manufacturer |
OrthoPediatrics Corp 2850 Frontier Dr Warsaw IN 46582-7001
|
For Additional Information Contact | Mallory Trusty 574-268-6379 |
Manufacturer Reason for Recall | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On September 12, 2022, the firm notified distributors of the recall. Distributors were asked to notify and retrieve affected devices from end users.
Affected product must be returned to OrthoPediatrics. Replacement product will be provided. Customers should contact customer service to arrange return of the affected product.
Customers who have patients in frames should be made aware of the possibility of Bolt breakage and continue monitoring their patients.
Any questions regarding this recall can be directed to Joel Batts, Senior VP of Clinical and Regulatory Affairs, at OrthoPediatrics at jbatts@orthopediatrics.com or 574-367-5396. |
Quantity in Commerce | 1354 (594 US) |
Distribution | Domestic distribution to
Foreign distribution to |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = OSN
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