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Stryker Modular Replacement System Curved Cemented Stem recallZ-0925-2008 · Stryker Howmedica Osteonics Corp. · initiated Nov 15, 2007

Terminated All recalls posted in February 2008

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

Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.

FDA root cause category: Process design

What the company is doing

On November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633.

Recall details

Recall number
Z-0925-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 15, 2007
Posted by the FDA
Feb 26, 2008
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
803 total, all sizes
Product code
JDI
FDA submissions
K952970
Distribution
Nationwide Distribution

Product description

Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem. Catalog Number: 6485-3-713; Stryker Orthopaedics Mahwah, NJ 07430

Code information (models, lots, serial numbers)

Catalog Number: 6485-3-713; Lot Codes: LCDCE,LCDE1, TEC027, TEC055, TEC055B, TEC055C, TEC087, TEC087A, TEC087A1, TEC087B, TEC087B1, TEC087C, TEC087D, TEC097E, TEC257, TEC283A.

Other devices under the same FDA submission

1 device cleared under K952970 — the recall does not name any of them by identifier. 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 45947).

Sources and updates

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