4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. recall
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand…
Why was 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. recalled?
Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only
- Product
- 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand…
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 24
- Distribution
- Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
- Recall date
- November 28, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)