Z-3106-2011

Depuy Mitek Ratchet Handle with Quick Connect

Name: Z-3106-2011 Depuy Mitek Ratchet Handle with Quick Connect
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2011-06-27
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2011-06-27 / Terminated

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws... on 2011-06-27. The reason FDA records is "Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3106-2011
Status: Terminated
Initiated: 2011-06-27
Posted: 2011-08-31
Terminated: 2012-01-19
Recalling firm: DePuy Mitek, Inc.
Product: Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic).
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Quick Disconnect Ratchet Handle may slip up the driver shaft or disengage leaving the shaft in the screw head.
FDA root cause: Process change control
Action: Depuy Mitek issued Original Customer Notification Letter on 6/27/11 and an Updated letter to clarify the lot number information sent 6/29/11. Hospitals requested to immediately check all inventories for affected product and return for repalcement product. Also notify surgeons aware of this potential issue and potential risk of a delay in surgery. questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.
Quantity in commerce: 75 units
Distribution: Nationwide distribution.
Product codes and lots: Finished Goods (Box label) Lot Numbers: 1105101 and 1106132. Component lot number Etched on Reusable Handle 1012001 and 1106001

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)