Biomet, Inc. Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448.
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
Lot 743430.
Products Sold
Lot 743430.
Biomet, Inc. is recalling Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, due to Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.
Recommended Action
Per FDA guidance
Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.
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 noticePage updated: Jan 10, 2026