FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
- Recall number
- Z-0879-2016
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
- Status
- Terminated
- Initiated
- 2016-01-21
- Posted
- 2016-02-25
- Terminated
- 2017-06-08
- Reason
- During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- Root cause
- Under Investigation by firm
- Action
- Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided.
- Quantity
- 147,838 units in total
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Catalog number 1806-0090S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MAY
- 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