3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking
FDA device recall Z-2796-2015 · posted 2015-09-18 · Terminated
Recall details
- Recalling firm
- OrthoPediatrics Corp
- Reason for recall
- The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
- Action taken
- OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 5
- Distribution
- Domestic: TN, IA Foreign: England VA/DOD: None
- Date initiated
- 2015-07-28
- Date posted
- 2015-09-18
- Date terminated
- 2016-03-17
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM (K111086) | OrthoPediatrics Corp. | 2011-06-17 |