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Stryker Orthopaedics Cancellous Bone Screw recallZ-0483-2014 · Stryker Howmedica Osteonics Corp. · initiated Oct 1, 2013

Class II Terminated All recalls posted in December 2013

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

Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.

FDA root cause category: Labeling mix-ups

What the company is doing

Stryker sent notification letters/accountability forms via Fed Ex on October 1, 2013, with return receipt. to branches/agencies and hospital risk management, chief of orthopedics and surgeons. Domestic branch locations were notified by e-mail on 9/16/2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax the Product Recall Acknowledgement Form to 855-251-3635, return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430. Customers were instructed to attach the fluorescent organge PRODUCT REMEDIATION sticker to their return, indicating the Produc Remediation # RA 2013-145. Mark the outer box with the words "Product Recall." Customers with questions were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5000.

Recall details

Recall number
Z-0483-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 1, 2013
Posted by the FDA
Dec 11, 2013
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units
Product code
HWC
FDA submissions
K894124
Distribution
Nationwide Distribution

Product description

Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.

Code information (models, lots, serial numbers)

1) 6.5 mm Cancellous Bone Screw 25mm Catalog No: 2030-6525-1 Lot code MMLNLA  2) 5.5 Cancellous Bone Screw 40 mm Catalog No: 2029-5540-1 Lot Code MMLMJ1

Other devices under the same FDA submission

7 devices cleared under K894124 — 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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