Recalls / —

—#206154

Product

X3 TRIATHLON CS INSERT NO 6 11 MM

FDA product code

MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K172634

Affected lot / code info

Part No. 5531-G-611-E; GTIN: 07613327337341; Lot No. HL7228; Expiration Date: 11/08/2028.

Why it was recalled

Potential packaging breaches of inner blister and outer sterile blister.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm

Howmedica Osteonics Corp.

Address

325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.

Timeline

Recall initiated

2024-02-06

Posted by FDA

2024-03-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.