Recall Z-1941-2013
OrthoPediatrics Corp · initiated July 24, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
Codes / lots: LOT 91300335 - Catalogue Number 01-1050-0002
Reason for recall
OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
FDA-determined cause: Process design
Action taken
On 7/24/13, OrthoPediatrics notified their consignees of this URGENT MEDICAL DEVICE RECALL via phone call. A follow-up email message was then sent with the recall notification, and then a hard copy of the notice was sent via certified letter. The notification addresses the affected product, recall issue, reply form instructions, and directs consignees to return affected product to OrthoPediatrics via a Fed-Ex return prepaid pouch. The firm directs consignees to forward the notification and reply form if the product was further distributed.
Details
- Recall number
- Z-1941-2013
- Initiated
- July 24, 2013
- Posted by FDA
- August 9, 2013
- Terminated
- August 26, 2013
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 68
- Distribution
- Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
- Recalling firm
- OrthoPediatrics Corp, Warsaw, IN