Recall Z-1833-2011 ยท FZX Guide, Surgical, Instrument
Biomet, Inc.
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.
| Date | Mar 28, 2011 (initiated Feb 10, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process change control |
| Action | 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 |
| Quantity | 17 |
| Distribution | Foreign only; UK, Malta, The Netherlands, Italy, Turkey, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.