Stryker Howmedica Osteonics Corp.: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

Agency Publication Date: February 25, 2016

Affected Products

Product: Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 0152-0218S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 0190-2000S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 12106450S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1210-6451S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1213-9091S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1320-0016S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-0051S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-0080S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-0083S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-0084S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-0085S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-0090S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-0093S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-1250S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-1417S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-3030S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Product: Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Catalog number 1806-3031S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73156

Status: Resolved

Manufacturer: Stryker Howmedica Osteonics Corp.

Manufactured In: United States

Units Affected: 18 products (147,838 units in total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products