Recall Z-1833-2011
Biomet, Inc. · initiated February 10, 2011
Product
REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide.
Codes / lots: LOT 32-485050 LOT NO. SA10 81254
Reason for recall
Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position.
FDA-determined cause: Process change control
Action taken
The firm, Biomet, sent a "FIELD SAFETY NOTICE" dated February 11, 2011 to all customers (heads of Orthopaedic Departments/Operating Departments /Sterile Services Departments/Procurement /Supplies/ Risk Management). The notice described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the product; return to Biomet or their local Biomet distributor; ensure that the operating staff are made aware of this issue, and complete and return the FAX BACK RESPONSE FORM to Biomet UK Ltd or their local Biomet distributor via fax at +44 (0) 1656 645454. If you have any questions regarding this communication, please contact the Regulatory & Compliance Manager at +44 (0) 1793 645317 or email: edward.spearpoint@biometeurope.com.
Details
- Recall number
- Z-1833-2011
- Initiated
- February 10, 2011
- Posted by FDA
- March 28, 2011
- Terminated
- May 16, 2011
- Product code
- FZX – Guide, Surgical, Instrument
- Quantity
- 17
- Distribution
- Foreign only; UK, Malta, The Netherlands, Italy, Turkey, Switzerland.
- Recalling firm
- Biomet, Inc., Warsaw, IN