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Recall Observatory FDA recall evidence

Device product

3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

Z-1710-2016

April 18, 2016

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 73945
Status
Terminated
Classification
Class II
Quantity
1274 units
Official record key
device-enforcement:Z-1710-2016

Official wording

Reason: The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.

Code information: Catalog ID 03.010.100S Lot # 5525872, 6153368, 6530901, 5548707, 6197315, 6581051 5575918, 6199232, 6676406, 5603463, 6231850, 6721724 5649117, 6256560, 6734876, 5668880, 6305842, 6808463 5724639, 6319050, 6831468, 5742276, 6320150, 6997294 5807341, 6343980, 7039877, 6012770, 6401819, 7052565 6045597, 6448707, 7081479, 6057914, 6472100, 7378832 6108342, 6501856, 7410311, 6142443, 6503351, 7466207 7554670, 7620971, 7675571, 7711694, 7801251, 7918026 9815103, 9828932, 9905850, 9939769, H033348

Distribution pattern: US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging may be compromised