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Orthopedic devices

242 product codes reviewed by the Orthopedic panel. 17,143 510(k) clearances and 7,855 recalls in the FDA data, 79% of those recalls name a 510(k).

437510(k)s in 12 months

190recalls in 12 months

6,173recalls that name a 510(k)

Active product codes, Class I

Code	Device	Class	Recalls, 12 mo
LXH	Orthopedic Manual Surgical Instrument	1	8
JDZ	Mixer, Cement, For Clinical Use	1	3
HTW	Bit, Drill	1	2
HWA	Impactor	1	2
HWX	Tap, Bone	1	2
HXI	Passer, Wire, Orthopedic	1	1