Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Zimmer Inc. is recalling Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular due to The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
Recommended Action
Per FDA guidance
Consignees were notified via letter dated August 23, 2005 or by email.
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