FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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.
- Recall number
- Z-1818-2009
- Recalling firm
- Stryker 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.
- Status
- Terminated
- Initiated
- 2006-11-17
- Posted
- 2009-08-18
- Terminated
- 2009-08-20
- Reason
- 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
- 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
- 1270
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- n/a
- 510(k) numbers
- ["K051590"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28