ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediat
FDA device recall Z-2560-2014 · posted 2014-08-29 · Terminated
Recall details
- Recalling firm
- OrthoPediatrics Corp
- Reason for recall
- Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
- Action taken
- OrthoPediatrics sent a Notification letter dated July 25, 2014 to all affected customers. The letter Identified the affected product, problem and actions to be taken. The letter informed customers to take immediate possession of all affected product within their control and at any of their health care facilities and immediately return the recalled device(s) to OrthoPediatrics Corp. This notice and the attached Reply Form should be forwarded if the affected product was further distributed. .
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 56 units
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2014-07-25
- Date posted
- 2014-08-29
- Date terminated
- 2015-05-19
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM (K130217) | OrthoPediatrics Corp. | 2013-06-20 |