Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to
FDA device recall Z-2371-2008 · posted 2008-09-29 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The blades will oxidize after the first cleaning.
- Action taken
- Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GFA
- Quantity affected
- 141 of all products
- Distribution
- Nationwide and China.
- Date initiated
- 2008-07-18
- Date posted
- 2008-09-29
- Date terminated
- 2009-06-26
- Location
- Warsaw, IN
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