Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75792

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 09, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Howmedica Osteonics Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0880-2017
Recall number
Z-0880-2017
Initiated
November 09, 2016
Classification
Class II
Status
Terminated
Quantity
2,084 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging revealed the seal integrity of the pouch may be compromised
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing error
Sterility assurance reason.sterility_assurance · v1.0.0
packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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