CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R recalled

Stryker Howmedica Osteonics is recalling GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma, distributed nationwide in the US. The recall was initiated on 9 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGAM Kirschner Wire - Manufacturing Part Number 12106450S, Lot #'s K0800BB, K0800BC, K0800BD, K0800BE, K0800BF, K0800C0, K081720, K081721, K0810872, K081723, K081727, K082C8B, K084F89, K084F98, K08683D, K08683E, K086841, K08820B, K089AF5, K08E1E1, K0911F4, K09379B, K096A26, K096A2A, K09A2C, K098213, K098215, K099AA0, K09AD33, K09BA4F, K09D564, K09F026, K0A1EF8, K0A1EFA, KoA1EFB, K0A38FB, K0A63AB, K0A63AC and K0A7BC1 T2 K-Wire - Manufacturing Part Number 18060050S, Lot #'s K084FBF, K0920A4, K0A1EFD, K093747, K0937C4, K09BA53, K09BA54, K09BA55 and K09BA56 T2 K-Wire Recon - Manufacturing Part Number 18063030S, Lot #'s K086847, K08E1E9 and K099AA8

Quantity recalled2,084 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0880-2017
FDA event ID: 75792
Recalling firm: Stryker Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 9 Nov 2016
FDA classified: 22 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

9 Nov 2016	Recall initiated by company
22 Dec 2016	Classified by FDA	+43 days
28 Dec 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

Where it was distributed

Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.

Nationwide California

Questions about this recall

Why was it recalled?

Which lots are affected?

GAM Kirschner Wire - Manufacturing Part Number 12106450S, Lot #'s K0800BB, K0800BC, K0800BD, K0800BE, K0800BF, K0800C0, K081720, K081721, K0810872, K081723, K081727, K082C8B, K084F89, K084F98, K08683D, K08683E, K086841, K08820B, K089AF5, K08E1E1, K0911F4, K09379B, K096A26, K096A2A, K09A2C, K098213, K098215, K099AA0, K09AD33, K09BA4F, K09D564, K09F026, K0A1EF8, K0A1EFA, KoA1EFB, K0A38FB, K0A63AB, K0A63AC and K0A7BC1 T2 K-Wire - Manufacturing Part Number 18060050S, Lot #'s K084FBF, K0920A4, K0A1EFD, K093747, K0937C4, K09BA53, K09BA54, K09BA55 and K09BA56 T2 K-Wire Recon - Manufacturing Part Number 18063030S, Lot #'s K086847, K08E1E9 and K099AA8

Where was it sold?

Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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21 Sep 2016Device	CLASS II	Stryker Orthopaedics Patella Assembly Instrument recalled	Stryker Howmedica Osteonics	Device Malfunction	Nationwide

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