NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
- Company
- Howmedica Osteonics Corp.
- Recall Initiated
- February 6, 2024
- Posted
- March 6, 2024
- Recall Number
- Z-1264-2024
- Quantity
- 18 units (US); 5 units (OUS)
- Firm Location
- Mahwah, NJ
Reason for Recall
Potential packaging breaches of inner blister and outer sterile blister.
Distribution
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Lot / Code Info
Part No. 5537-G-411-E; GTIN: 07613327287691; Lot No. E97TH6; Expiration Date: 10/07/2028.
Root Cause
Packaging
Action Taken
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.