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U.S. Department of Health and Human Services

Class 2 Device Recall Rees Insulated Forceps

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  Class 2 Device Recall Rees Insulated Forceps see related information
Date Initiated by Firm June 25, 2010
Date Posted September 09, 2010
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-2392-2010
Recall Event ID 56133
Product Classification Forceps, general & plastic surgery - Product Code GEN
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
Code Information Lot Number: 042308D08, 112108K08, 031309C09, 041009D09, 042310B10, 021910B10, 092707I07, 102607J07, 032607C07, and 041607D07.
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Christy Cain
904-741-4400
Manufacturer 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 2		 Manufacturing material removal
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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