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U.S. Department of Health and Human Services

Class 3 Device Recall Stryker

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 Class 3 Device Recall Strykersee related information
Date Initiated by FirmFebruary 08, 2005
Date PostedMay 03, 2005
Recall Status1 Terminated 3 on May 20, 2005
Recall NumberZ-0786-05
Recall Event ID 31145
Product Classification Arthroscope - Product Code HRX
ProductStryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
Code Information The following part numbers and subsequent lot numbers are involved in this recall. Part number 0275-950-000: 04109232, 0419292, 04109312, 04119712, 04119732, 04363AG2, 04364AG2. Part number 0275-951-012: 04098532, 04098752, 04098852, 04098872, 04109172, 04109212, 04109292, 4109312, 04119352, 04119392, 04119432, 04119712, 04129892,04129912, 04355AG2, 04357AG2, 04358AG2, 04363AG2. Part number 0275-951-012S1: 4098812, 04119672. Part number 0275-951-200: 04098492, 04362AG2. Part number 0275-952-000: 04108972, 04113432, 04129812, 05013AG2. Part number 0375-950-000: 0409522, 04112882, 04112962, 04123162. Part Number 0975-950-012: 04102542, 04102662, 04123162, 04123202. Part number 0375-951-012: 04092262, 4092362, 04092402, 04112862, 04112882, 04112902, 04113042, 04113082, 04123142, 04123202. Part Number 0375-951-200: 04113042. Part number 0275-950-012: 04098812, 04108912, 04109152, 04119512, 0411612, 0411712, 04129792, 04357AG2. Part Number 0275-951-000: 04098532, 04098552, 04098752, 04098772, 04098832, 04098852, 04098892, 04108912, 04109152, 04109172, 04109192, 04109232, 04109252, 04109292, 04119412, 04119432, 04119612, 04119632, 04119712, 04119732, 04129792, 04129852, 04129912, 04129972, 04352AG2, 04352AG2. Part Number 0375-951-000: 04092262, 4092362, 04102542, 04102662, 04102682, 04102762, 04112882, 04113002, 04113082, 04123162, 04123202, 04123222. Part number 0375-952-000: 04092522, 04102602, 04113042, 04123222.
FEI Number 2936485
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
Manufacturer Reason
for Recall		The device has the potential to overheat and cause patient burns during use.
FDA Determined
Cause 2		Process control
ActionAll consignees will be immediately notified via phone calls and a mailed Urgent Product Recall Notice (2 recipients per consignee, Risk Manager and OR Supervisor)
Quantity in Commerce28935 boxes, 5 units per box.
Distribution740 domestic consignees
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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