Model No. 01-1503-0032 (Adolescent 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.
FDA Recall Z-0219-2020 · Posted None
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Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeHSB
Date Initiated2019-08-19
Date Terminated2020-04-30
Product Quantity969 total
Reason for Recall
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Firm Action
On August 19, 2019, the firm notified customers of the issue via emailed notice titled Urgent Medical Device Recall. Customers were informed of the issue of binding between the attachment bolt and the intramedullary nail. The firm asked customers to return all attachment bolts in the field. The issue does not impact intramedullary nails that have been implanted. No additional corrective actions need to be taken for product already implanted.
Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory
Affairs, at OrthoPediatrics at [email protected] or 574-267-0897.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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