Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall iQ Intelligent Device

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall iQ Intelligent Device see related information
Date Initiated by Firm July 08, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 09, 2012
Recall Number Z-0447-2012
Recall Event ID 60421
Product Classification Motor, surgical instrument, ac-powered - Product Code HBF
Product Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***"

The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws).
Code Information Model #- 72-1000 Serial #'s: 000007, 000009, 000010, 000011, 000012, 000013, 000017, 0G0014, 0G0018, 0G0019, 0K0001, 0K0003, 0K0006, 0K0007, 0K0008, 0K0009, 0K0011, 0K0012, 0K0013, 0K0014, 0K0015, 0K0016, 0K0017, 0K0019, 0K0020, 0K0021, 0K0022, 0L0001, 0L0002, 0L0003, 0L0004, 0L0005, 0L0006, 0L0007, 0L0008, 0L0009, 0L0010, 0L0011, 0L0014, 0L0015, 0L0016, 0L0017, 0L0018, 0L0019, 0L0020, 0L0022, 0L0023, 0L0024, 0L0026, 0L0028, 0L0029, 0L0030, 0L0031, 0L0032, 0L0033, 0L0034, 0L0035, 0L0037, 0L0038, 0L0039, 0L0041, 0L0042, 0L0044, 0L0045, 0L0046, 1A0004, 1A0005, 1A0012, 1A0014, 1A0016, 1A0019, 1A0020, 1A0021, 1A0022, 1A0024, 1A0026, 1A0028, 1A0031, 1A0033, 1A0034, 1A0036, 1A0037, 1A0041, 1A0042, 1A0043, 1A0044, 1A0046, 1A0047, 1A0048, 1A0051, 1A0052, 1A0053, 1A0055, 1A0056, 1A0057, 1A0059,1A0062, 1A0064, 1A0067, 1A0069, 1A0070, 1A0072, 1A0073, 1A0079, 1A0081, 1A0084, 1A0085, 1A0086, 1A0088, 1A0089, 1A0090, 1A0091, 1A0093, 1A0095, 1A0096, 1A0097, 1A0098, 1A0099, 1A0100, 1A0101, 1A0102, 1A0103, 1A0105, 1A0106, 1A0107, 1A0108, 1A0113, 1A0117, 1A0118, 1A0119, 1A0120, 1A0123, 1A0125, 1A0126, 1A0127, 1A0128, 1A0129, 1A0130, 1A0131, 1A0133, 1A0134, 1A0135, 1A0136, 1A0137, 1A0138, 1A0142, 1A0144, 1A0145, 1A0148, 1A0149, 1A0152, 1A0153, 1A0156, 1A0158, 1A0171, 1A0174, 1A0176, 1A0198, 1B0010, 1C0004, 1C0014, 1C0023, 1C0025, CK 0030, cK0011, CK0024, CK0025, CK0026, CK0027, CK0028, CK0029, CK0032, CK0033 
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Christy Cain
904-741-4400
Manufacturer Reason
for Recall		 Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip.
FDA Determined
Cause 2		 Component design/selection
Action Biomet Microfixation called, emailed, or sent an Urgent Medical Device Recall letter dated July 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the remaining device(s) at their facility and return immediately to PIVOT for the required software upgrade. Customers were also instructed to return the attached reconciliation form to: PIVOT International 10916 Strang Line Road Lenexa, KS 66215 Attn: Julie Lawrence For any questions regarding this recall call 1-800-874-7711 or 904-741-4400, ext 9468.
Quantity in Commerce 161 devices were distributed.
Distribution Worldwide Distribution - USA AZ, CA, CO, DC, FL, GA, HI, ID, IL, IN, KS, LA, NC, NH, NY, OK, OR, PA, TN, TX, and WI and the countries of Argentina, Brazil, France, Italy, Japan, South Africa, and Thailand.
Total Product Life Cycle TPLC 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.
-
-