Recall Z-0108-2011
Biomet Microfixation, Inc. · initiated August 31, 2010
Product
2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 MM TITANIUM, BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, www.biometmicrofixation.com. (3.) #01-9205, LOT 999999, QTY 00001, 4 HOLE PLATE, STRAIGHT, LONG, 1.0 MM, CE 0086
Codes / lots: Lot 120150.
Reason for recall
Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).
FDA-determined cause: Other
Action taken
Biomet Microfixation sent URGENT MEDICAL DEVICE RECALL NOTICES dated August 31, 2010 to its customers and distributors, identifying the affected product and actions to be taken by customers. Customers were requested to check their inventory for product and return any affected product to Biomet Microfixation. Customer questions or concerns should be directed to Laura Sabo, VP Global QA/RA at 904-741-4500.
Details
- Recall number
- Z-0108-2011
- Initiated
- August 31, 2010
- Posted by FDA
- October 20, 2010
- Terminated
- November 19, 2010
- Product code
- JEY – Plate, Bone
- Quantity
- 56
- Distribution
- Worldwide Distribution: USA including states of Hawaii and Kansas, and the countries of Australia, Denmark, Italy, Jordan, and South Africa.
- Recalling firm
- Biomet Microfixation, Inc., Jacksonville, FL