Recall Z-2392-2010
Biomet Microfixation, Inc. · initiated June 25, 2010
Product
BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS STEEL, NYLON, ***NON-STERILE PRODUCT***. The Rees Insulated Forceps are used during surgery to grasp, dissect and coagulate selected tissue. Distributed by: BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218, www.biometmicrofixation.com
Codes / lots: Lot Number: 042308D08, 112108K08, 031309C09, 041009D09, 042310B10, 021910B10, 092707I07, 102607J07, 032607C07, and 041607D07.
Reason for recall
The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used.
FDA-determined cause: Manufacturing material removal
Action taken
Biomet Microfixation issued a letter dated July 2010 to their consignees. Each consignee was ask to discontinue use of the affected product and return the product back to the company for credit. Biomet asked their customers to complete a "Inventory Reconciliation" form and fax the completed form to Biomet Microfixation. If the consignee has further distributed the product, the consignee is asked to contact their customers. Biomet Microfixation can be contacted at 904 741-4400, ext 468.
Details
- Recall number
- Z-2392-2010
- Initiated
- June 25, 2010
- Posted by FDA
- September 9, 2010
- Terminated
- June 21, 2011
- Product code
- GEN – Forceps, General & Plastic Surgery
- Quantity
- 130 units
- Distribution
- Worldwide Distribution: USA including states of CA, FL, GA, ID, IL, IN, MA, MD, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, WA, and WI, and countries of Norway, Canada, and Mexico.
- Recalling firm
- Biomet Microfixation, Inc., Jacksonville, FL