Date Initiated by Firm | January 21, 2016 |
Date Posted | February 25, 2016 |
Recall Status1 |
Terminated 3 on June 08, 2017 |
Recall Number | Z-0869-2016 |
Recall Event ID |
73156 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophil - Product Code MAY
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Product | Stryker, Gamma K-Wire 3.2x450 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. |
Code Information |
Catalog number 12106450S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
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For Additional Information Contact | Mr. Eric Petschler 201-831-5000 |
Manufacturer Reason for Recall | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided. |
Quantity in Commerce | 147,838 units in total |
Distribution | US Nationwide Distribution |
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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