Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.
Recall
- Recall Number
- Z-2054-2013
- Event Number
- 65787
- Firm
- Stryker Craniomaxillofacial Division
- FEI Number
- 3005101424
- Product Code
- GXP
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- July 30, 2013
- Posted
- August 26, 2013
- Terminated
- April 17, 2014
- Address
- 750 Trade Centre Way, Ste 200, Portage, MI, 49002-0482
Description
Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.
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.
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: [email protected] 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.
Worldwide Distribution - USA (nationwide) including the countries through Stryker Distribution: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom, Argentina, Australia, Brazil, Jordan, Kingdom of Saudi Arabia, Kuwait, Latin America (others), New Zealand, Russia, Singapore, South Africa, and United Arabian Emirates.
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