Z-1704-2009

IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic...

Name: Z-1704-2009 IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic...
Creator: Smith & Nephew Inc
Published: 2009-01-22
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-01-22 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery on 2009-01-22. The reason FDA records is "Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1704-2009
Status: Terminated
Initiated: 2009-01-22
Posted: 2009-08-04
Terminated: 2011-08-18
Recalling firm: Smith & Nephew, Inc.
Product: IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.
Quantity in commerce: 99 units
Distribution: Distribution to USA, Switzerland and Australia.
Product codes and lots: Lot Number: 08K22270

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)