Recall Z-1798-2015
Biomet, Inc. · initiated April 22, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Codes / lots: Part 32-423101 Lot 414930 Part 32-423102 Lot 116490 Part 32-423106 Lot 785220 Part 32-423107 Lot 873780 Part 32-423108 Lot 070420 and 785250 Part 32-423109 Lot 670630 Part 32-423115 Lot 672920 Part 32-423119 Lot 785290 Part 32-423116 Lot 073640 Part 32-423101 Lot 785170 Part 32-423102 Lot 785180 Part 32-423109 Lot 785260 Part 32-423124 Lot 024760 Part 32-423110 Lot 785270
Reason for recall
The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.
FDA-determined cause: Process control
Action taken
On 4/22/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications, dated April 22, 2015 were sent to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are required to immediately locate and remove the affected product from circulation, follow the instructions on the "Response Form," and e-mail a copy of the completed form to the designated e-mail address prior to returning the product. Additionally, if the affected product has been further distributed, the necessary personnel must notified via the "Dear Risk/Recall Manager" notice. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-1798-2015
- Initiated
- April 22, 2015
- Posted by FDA
- June 15, 2015
- Terminated
- March 22, 2016
- Product code
- HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Quantity
- 27
- Distribution
- Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.
- Recalling firm
- Biomet, Inc., Warsaw, IN