Z-0161-06

DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220

Name: Z-0161-06 DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220
Creator: Depuy Mitek, a Johnson & Johnson Co.
Published: 2005-08-09
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2005-08-09 / Terminated / root cause: labeling and UDI

FDA source

Depuy Mitek, a Johnson & Johnson Co. began a recall of DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220 on 2005-08-09. The reason FDA records is "Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0161-06
Status: Terminated
Initiated: 2005-08-09
Posted: 2005-11-18
Terminated: 2006-05-02
Recalling firm: DePuy Mitek, Inc.
Product: DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer
Root cause tag: labeling and UDI
FDA root cause: Other
Action: DePuy Mitek notified the accounts by US Mail on 8/09/05. Accounts were requested to return product.
Quantity in commerce: 5 boxes /10 units (50 pieces)
Distribution: CA, NC, VA
Product codes and lots: Lot Number: JBV04259

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