Biomet, Inc. Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Lot 918930, exp. 2012-02.
Products Sold
Lot 918930; exp. 2012-02.
Biomet, Inc. is recalling Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, ste due to Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.
Recommended Action
Per FDA guidance
The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IA, SD
Page updated: Jan 10, 2026