Z-0740-2012

U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is...

Name: Z-0740-2012 U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is...
Creator: Ortho Development Corporation
Published: 2011-12-19
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2011-12-19 / Terminated / root cause: design

FDA source

Ortho Development Corporation began a recall of U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular... on 2011-12-19. The reason FDA records is "Tip of hex-head screwdriver may break off during use in hip replacement procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0740-2012
Status: Terminated
Initiated: 2011-12-19
Posted: 2012-01-13
Terminated: 2012-08-27
Recalling firm: Ortho Development Corp.
Product: U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Tip of hex-head screwdriver may break off during use in hip replacement procedure.
Root cause tag: design
FDA root cause: Device Design
Action: Ortho Development Corporation sent an "URGENT!! DEVICE RECALL" letter dated December 19, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check to see if they have the affected device. Customers who have the device are to return the device to the firm, immediately. The firm will provide suitable replacements. Contact the Regulatory Affairs Manager for questions regarding this notice.
Quantity in commerce: 37 units
Distribution: Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT.
Product codes and lots: Lot numbers 1365304, 1365305.

Product code LZO

K103384Class IIEscalade Acetabular Cup SystemOrtho Development / cleared 2011-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)