Zimmer Inc. Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX, REF 775-01. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX, REF 775-01.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lots 12XM, 16BT, 18FY, 19GS, 20YQ, 21CB and 25ZP.
Products Sold
Lots 12XM, 16BT, 18FY, 19GS, 20YQ, 21CB and 25ZP.
Zimmer Inc. is recalling Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX, REF 775-01. due to The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Recommended Action
Per FDA guidance
The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S. For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.
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