Recall Z-2206-2010 ยท DZL Screw, Fixation, Intraosseous
Biomet Microfixation, Inc.
BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
| Date | Aug 11, 2010 (initiated Mar 17, 2010) |
| Status | Terminated |
| Reason | Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws. |
| Root cause | Other |
| Action | Biomet Microfixation is recalling their 1.5x4mm HT X-drive Screws Lot Number 148530 after receiving a customer reported finding one 3.5MM screw in a package labeled as containing 4.0MM screws. Lot 148530 was packaged into one count packages 91-1504 and 5 count packages 95-1504. The 1 and 5 count packages were distributed between 12/10/2009 and 02/01/2010. Beginning on 03/17/2010 customers identified as receiving Lot 148530 HT X-drive Screws were notified of the recall by a combination of an Urgent Medical Device Recall Notice letter, e-mail, fax and telephone calls. Customers were instru |
| Quantity | 1247 screws |
| Distribution | Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM Walter Lorenz Surgical, Inc., Sep 28, 1995 |