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Stryker Orthopaedics recallZ-0388-2013 · Stryker Howmedica Osteonics Corp. · initiated Aug 17, 2012

Class II Terminated All recalls posted in November 2012

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 has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.

FDA root cause category: Mixed-up of materials/components

What the company is doing

The firm, Stryker Orthopaedics, notified Domestic locations of this action by e-mail on August 6, 2012 and foreign locations of this action by e-mail on August 7, 2012. Stryker follow-up by sending an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated August 17, 2012 to their consignees/customers via Fed Ex with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and return affected product to Attn: Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430 (attach fluorescent orange sticker and mark box with words "Product Recall"), or contact your Stryker Sales Representative to arrange for return of the product ,and complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.

Recall details

Recall number
Z-0388-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 17, 2012
Posted by the FDA
Nov 19, 2012
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
Approximately 358 units
Product code
HWC
FDA submissions
K894124
Distribution
Worldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK.

Product description

Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.

Code information (models, lots, serial numbers)

Catalog No: 2030-6535-1 Lot Code: MLDNAV, MLDXV2, MLH11M, MLH17R, MLH3K8, MLH4L6, MLH7RV, MLHK1X, MLHL99, MLJDJT Ref 2030-6535-1

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 63358).

Sources and updates

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