Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Lot Codes / Batch Numbers
Lot #: 633811, 633851, 738381, 738391, 770021, 777371, 792441, 817581, 831031, 878311, 905531, 905541, 907051, 944231, and 949371.
Products Sold
Lot #: 633811, 633851, 738381, 738391, 770021, 777371, 792441, 817581, 831031, 878311, 905531, 905541, 907051, 944231, and 949371.
A medical device manufacturer is recalling Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by due to Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Recommended Action
Per FDA guidance
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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