Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PL

FDA device recall Z-0447-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

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.

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.

Root cause

Component design/selection

Status

Terminated

Product code

HBF

Quantity affected

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 Thai

Date initiated

2011-07-08

Date posted

2012-01-11

Date terminated

2012-03-09

Location

Jacksonville, FL