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Trident PSL HA Solid Back 50 mm recallZ-1043-2015 · Stryker Howmedica Osteonics Corp. · initiated Dec 15, 2014

Class II Terminated All recalls posted in February 2015

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 Stryker 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

Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

FDA root cause category: Process control

What the company is doing

Stryker sent an Urgent Medical Device letter dated January 7, 2015, with a Recall Notification/Acknowledgement Form via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Recall Acknowledgement Form to [email protected] or fax to 1-855-251-3635. Customers should return the affected product to: Attention: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Customers with questions should call 201-831-6365. For questions regarding this recall call 201-831-5000.

Recall details

Recall number
Z-1043-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 15, 2014
Posted by the FDA
Feb 3, 2015
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
seven units
Product code
MEH
FDA submissions
K983382
Distribution
Nationwide Distribution including NY, OH, PA, and TX.

Product description

Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.

Code information (models, lots, serial numbers)

510K 983382  Lot code 49073501

Other devices under the same FDA submission

9 devices cleared under K983382 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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