Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA w

FDA device recall Z-0388-2013 · posted 2012-11-19 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

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.

Action taken

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

HWC

Quantity affected

Approximately 358 units

Distribution

Worldwide distribution: USA (nationwide) and countries including: Canada, Belgium, Finland, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Portugal, Spain, Turkey and UK.

Date initiated

2012-08-17

Date posted

2012-11-19

Date terminated

2014-04-10

Location

Mahwah, NJ

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