Recall Z-2385-2011 ยท JEY Plate, Bone
Biomet Microfixation, Inc.
***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0.6 MM TITANIUM***NON-STERILE PRODUCT*** This titanium plate is used in the 1.5mm Lorenz Midface System which is indicated for use in trauma, neurosurgery, craniomaxillary reconstruction and orthognat
| Date | May 27, 2011 (initiated Jul 28, 2010) |
| Status | Terminated |
| Reason | Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold Long Double Y). |
| Root cause | Labeling mix-ups |
| Action | The firm, Biomet Microfixation, sent an "URGENT MEDICAL SAFETY ALERT NOTICE" letter dated July 28, 2010 to its customers/distributors. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their stock and ensure that the plates were properly distributed into their trays and that they have the sufficient quantity of plates that they need. In addition, they were instructed to complete and return the attached Inventory Reconciliation form via fax to: Attn: Customer Relations Specialist at 904-741-9425 and notify the recipient of this notice, i |
| Quantity | 180 |
| Distribution | Worldwide distribution: USA (nationwide) including states of: FL, IN, KY, MT, NC, NE, NY, OH, TX, VA, and WI; and countries including: Argentina, Canada, Colombia, Czech Republic, Japan, Korea, Mexico, Norway, South Africa, Spain and Turkey. |
| 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 |