Recall Z-0447-2012
Biomet Microfixation, Inc. · initiated July 8, 2011
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).
Codes / lots: 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…
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: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0447-2012
- Initiated
- July 8, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- March 9, 2012
- Product code
- HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered)
- Quantity
- 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.
- Recalling firm
- Biomet Microfixation, Inc., Jacksonville, FL