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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic tray
Regulation Description Manual surgical instrument for general use.
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOJH
Regulation Number 878.4800
Device Class 1

Device Problems
Adverse Event Without Identified Device or Use Problem 54
No Apparent Adverse Event 15
Appropriate Term/Code Not Available 14
Device Operates Differently Than Expected 8
Insufficient Information 7
Fracture 3
Component Missing 2
Biological Environmental Factor 2
Device Issue 1
Improper Flow or Infusion 1
Packaging Problem 1
Inaccurate Delivery 1
Detachment of Device or device Component 1
Total Device Problems 110

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Avid Medical, Inc. II Mar-19-2020
3 Customed, Inc II Apr-14-2016
4 Customed, Inc II Sep-03-2015
5 Medline Industries Inc II Feb-11-2020

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