Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 3970

FDA device recall Z-2054-2013 · posted 2013-08-26 · Terminated

Recall details

Recalling firm

Stryker Craniomaxillofacial Division

Reason for recall

Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause foreign body reaction including inflammation and might lead to the need for revision surgery.

Action taken

Stryker sent an Urgent Medical Device Recall Notices with attached Product Correction Bulletin dated, July 30, 2013, describing the product, problem and possible adverse events associated with the recall were sent to all affected customers. Customers were instructed to pass the notice and bulletin to all individuals who may be using the device, provided instructions on procedures which would help mitigate risk and return the customer response form to our Customer Service Team by email, fax or letter. Email: CMF-custserv@stryker.com Fax: 1-877-648-7114 Address: 750 Trade Centre Way, Suite 200 Portage, MI 49002 Customers responses will be tracked and non-responders will be contacted. Further questions please call (877) 534-2464.

Root cause

Package design/selection

Status

Terminated

Product code

GXP

Quantity affected

12,719

Distribution

Worldwide Distribution - USA (nationwide) including the countries through Stryker Distribution: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Luxembourg, Nether

Date initiated

2013-07-30

Date posted

2013-08-26

Date terminated

2014-04-17

Location

Portage, MI

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