Z-1818-2009

T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics The Surgical...

Name: Z-1818-2009 T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics The Surgical...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-11-17
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-11-17 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics The Surgical Protocol instructs surgeons on proper surgical... on 2006-11-17. The reason FDA records is "Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm)". 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-1818-2009
Status: Terminated
Initiated: 2006-11-17
Posted: 2009-08-18
Terminated: 2009-08-20
Recalling firm: Howmedica Osteonics Corp
Product: T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics The Surgical Protocol instructs surgeons on proper surgical technique for the T2 Ankle Arthrodesis Nail.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm).
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Important Product Correction Letters, dated November 17, 2006, were sent to all Stryker Branches/agencies via Federal Express. The letter stated the issue and asked consignees to examine their inventory and contact their sales reps. It also told them to destroy the affected Operative Techniques by cutting them in half and discarding them, complete the attached Acknowledgment Form, and fax a signed copy of that form to 201-831-6069. The letter stated that Stryker Orthopaedics Customer Service reps would place consignees' re-orders for the product being destroyed. Also, the letter stated that in the interim a correct revision of the Operative Technique could be found online. Customers are to contact Dave O'Dell at 201-831-5277 or Rita Intorrella at 201-831-5825 with any questions.
Quantity in commerce: 1270
Distribution: Nationwide Distribution
Product codes and lots: n/a

Product code HSB

K051590Class IIT2 Ankle Arthrodesis NailHowmedica Osteonics Corp. / cleared 2005-07-29

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)