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
This recall has been terminated (originally issued September 9, 2010).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- June 25, 2010
- Posted
- September 9, 2010
- Terminated
- June 21, 2011
- Recall Number
- Z-2392-2010
- Quantity
- 130 units
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used.
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.
Lot / Code Info
Lot Number: 042308D08, 112108K08, 031309C09, 041009D09, 042310B10, 021910B10, 092707I07, 102607J07, 032607C07, and 041607D07.
Root 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.