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Cerclage, Fixation

FDA product code JDQ · Class 2 · Orthopedic

938
Registered devices
2,614
Adverse events
15
Recalls
130
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2019-09-10Alto Development CorpSome Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,
2019-09-10Alto Development CorpSome Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,
2019-09-10Alto Development CorpSome Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,
2019-09-10Alto Development CorpSome Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,
2019-09-10Alto Development CorpSome Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,
2015-10-19Synthes (USA) Products LLCCertain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to custome
2015-07-22Synthes (USA) Products LLCThe end cap may loosen and detach making the instrument non-functional. No injuries reported.
2015-05-29RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar,
2015-02-11EXP Pharmaceutical Services CorpEXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that
2014-06-11PIONEER SURGICAL TECHNOLOGY, INC.Lack of Sterility Assurance

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