| Class 2 Device Recall Triathlon Total Knee System | |
Date Initiated by Firm | February 06, 2024 |
Date Posted | March 06, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1261-2024 |
Recall Event ID |
94026 |
510(K)Number | K172634 |
Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
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Product | X3 TRIATHLON CS INSERT NO 6 11 MM |
Code Information |
Part No. 5531-G-611-E; GTIN: 07613327337341; Lot No. HL7228; Expiration Date: 11/08/2028. |
Recalling Firm/ Manufacturer |
Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
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Manufacturer Reason for Recall | Potential packaging breaches of inner blister and outer sterile blister. |
FDA Determined Cause 2 | Packaging |
Action | URGENT MEDICAL DEVICE RECALL notifications dated 02/06/2024 were distributed to consignees by mail. Consignees were asked to forward the provided recall notice to all individuals within the organization who need to be made aware and organizations who have consigned product, immediately check all stock and operating room storage for affected devices, quarantine and discontinue use of recalled devices, complete and return the provided Business Reply Form by email to strykerortho4004@sedgwick.com or by fax to 855-800-1093. Consignees are to contact their local sales office or Stryker Sales Representative for product replacement and inventory questions. Recalled devices are to be returned to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team, 325 Corporate Drive, Dock M-East, Mahwah, NJ 07430; include "Ref PFA 3524019" on shipment. Consignees with any questions are to call the firm at 201-831-5000 or by email at SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. An URGENT MEDICAL DEVICE RECALL UPDATE, dated 3/18/24, was sent to consignees. |
Quantity in Commerce | 24 units (US) |
Distribution | Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = MBH
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