Reported Feb 22, 2023 · Ongoing
Orthex Large Bone Shoulder Bolt, model no. AS-17
OrthoPediatrics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- Orthex Large Bone Shoulder Bolt, model no. AS-17
- Lot codes and dates
- UDI-DI00841132143155
- Lots921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E
- Amount recalled
- 1354 (594 US)
Why it was recalled
Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
This product could cause temporary or reversible health problems — stop using it.
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