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Class 2 Device Recall T2 K Wire |
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Date Initiated by Firm |
November 09, 2016 |
Create Date |
December 22, 2016 |
Recall Status1 |
Terminated 3 on March 27, 2019 |
Recall Number |
Z-0880-2017 |
Recall Event ID |
75792 |
Product Classification |
Rod, fixation, intramedullary and accessories, metallic and non-collapsible - Product Code NDE
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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 |
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 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
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For Additional Information Contact |
Mr. William Van Ryn 201-831-5000
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Manufacturer 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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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