Z-0880-2017Class II

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH...

Name: Z-0880-2017 GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2016-11-09
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2016-11-09 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2016-11-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0880-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-09
Posted: 2016-12-22
Terminated: 2019-03-27
Recalling firm: Howmedica Osteonics Corp
Product: 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
Product code: NDE Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Stryker sent an Urgent Medical Device Removal letter dated November 9, 2016, to all affected customers via UPS (with return receipt). Stericycle will be handling the returns. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inform users of the Medical Device Recall and forward the notice to all those individuals who need to be aware within their organization. Return all affected products available at their location to: Stryker C/O Stericycle 2670 Executive Dr., Suite A Indianapolis, IN 46241 Attn: RA 2016-169 - Event XXX Customers were also instructed to complete and sign the enclosed Business Reply Form and return to Stericycle. Customers with questions should call +1-201-851-6683. For questions regarding this recall call 201-831-5000.
Quantity in commerce: 2,084 units
Distribution: Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0880-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0880-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code NDE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)