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Triathlon recallZ-1263-2024 · Howmedica Osteonics Corp. · initiated Feb 6, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential packaging breaches of inner blister and outer sterile blister.

FDA root cause category: Packaging

What the company is doing

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 [email protected] 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 [email protected]. An URGENT MEDICAL DEVICE RECALL UPDATE, dated 3/18/24, was sent to consignees.

Recall details

Recall number
Z-1263-2024
Status
Open, Classified
Initiated by the company
Feb 6, 2024
Posted by the FDA
Mar 6, 2024
Recalling firm
Howmedica Osteonics Corp.
Quantity
39 units (US); 10 units (OUS)
Product code
MBH
FDA submissions
K172634
Distribution
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.

Product description

NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Code information (models, lots, serial numbers)

Part No. 5537-G-311-E; GTIN: 07613327288063; Lot No. EP81Y7, YL5VKA; Expiration Date: 10/07/2028.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

104 devices cleared under K172634 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94026).

Sources and updates

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