FDA Medical Device Recalls (openFDA)
Biomet Microfixation, Inc.: 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).
- Recall number
- Z-0447-2012
- Recalling firm
- Biomet Microfixation, Inc.
- 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).
- Status
- Terminated
- Initiated
- 2011-07-08
- Posted
- 2012-01-11
- Terminated
- 2012-03-09
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HBF
- Firm FEI
- 1032347
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28