Device product
Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Z-0218-2020
Product summary
- Event
- Event 83884
- Status
- Terminated
- Classification
- Class II
- Quantity
- 969 total
- Official record key
device-enforcement:Z-0218-2020
Official wording
Reason: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Code information: 173265-A 175220-A 177576-A 183279-A 187374-A 192277-A 192277-B 192431-A 192431-B
Distribution pattern: Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.
Derived failure modes
-
Unknown
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.