Zimmer Inc. Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 52.5 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-53-45 (00225305345). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 52.5 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-53-45 (00225305345).
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lots 24122200, 24730600, 25342400, 25765300, 60025157 and 60034732. ********Extended to include lots 24122600, 24122700, 24123000, 24667300, 24730700, 24730800, 25769900, 26003200, 26113700, 26435200, 60005229, 60019022, 60034734, 60034735, 60043306, 60043307 and 60043308.*********************
Products Sold
Lots 24122200, 24730600, 25342400, 25765300, 60025157 and 60034732. ********Extended to include lots 24122600, 24122700, 24123000, 24667300, 24730700, 24730800, 25769900, 26003200, 26113700, 26435200, 60005229, 60019022, 60034734, 60034735, 60043306, 60043307 and 60043308.*********************
Zimmer Inc. is recalling Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 52.5 mm length, 22-13- due to Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Recommended Action
Per FDA guidance
Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
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