BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS STEEL, NYLON, ***NON-STERILE PROD

FDA device recall Z-2392-2010 · posted 2010-09-09 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

Reason for recall

The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used.

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.

Root cause

Manufacturing material removal

Status

Terminated

Product code

GEN

Quantity affected

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.

Date initiated

2010-06-25

Date posted

2010-09-09

Date terminated

2011-06-21

Location

Jacksonville, FL