Z-1821-2009

Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma...

Name: Z-1821-2009 Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-06-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-06-18 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of... on 2009-06-18. The reason FDA records is "Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width". 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-1821-2009
Status: Terminated
Initiated: 2009-06-18
Posted: 2009-08-18
Terminated: 2012-08-27
Recalling firm: Howmedica Osteonics Corp
Product: Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.
Quantity in commerce: 13 total, (both products)
Distribution: Nationwide Distribution
Product codes and lots: Lot # 29233201; Exp. 2/3/2014

Product code KTT

K872224Class IIModified Trochanter Cable Grip SystemHowmedica Corp. / cleared 1987-08-17

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)