Z-2054-2013Class II

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

Name: Z-2054-2013 Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005...
Creator: Stryker Craniomaxillofacial Division
Published: 2013-07-30
License: https://open.fda.gov/license/

Stryker Craniomaxillofacial Division / initiated 2013-07-30 / Terminated / root cause: packaging

FDA source

Stryker Craniomaxillofacial Division began a recall of 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... on 2013-07-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2054-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-08-26
Terminated: 2014-04-17
Recalling firm: Stryker Craniomaxillofacial Division
Product: 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.
Product code: GXP Methyl Methacrylate For Cranioplasty
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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.
Quantity in commerce: 12,719
Distribution: 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.
Product codes and lots: Part 79-43903, Lot: IC01116, IC01130, IC01204, IC01233, IC01238 Part 79-43905 Lot: IC01084, IC01085, IC01086, IC01093, IC01123, IC01150, IC01166, IC01167, IC01168, IC01180, IC01188, IC01189, IC01190, IC01198, IC01199, IC01200, IC01213, IC01214, IC01229, IC01230, IC01239, IC01240, IC01245, IC01246, IC01270 Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154, IC01163, IC01164, IC01165, IC01179, IC01183, IC01184, IC01201, IC01202, IC01203, IC01231, IC01243, IC01244, IC01248, IC01249, IC01261, IC01264, Part 79-43015 Lot: IC01100, IC01114, IC01161, IC01162, IC01182, IC01211, IC01212, IC01227, IC01228, IC01241, IC01242, IC01252, IC01253, IC01254, IC01267 Part 397003 Lot: IC01092, IC01101, IC01102, IC01103, IC01104, IC01105, IC01106, IC01107, IC01115, IC01127, IC01131, IC01205, IC01220, IC01232, IC01234 Part 397005 Lot: IC01088, IC01094, IC01095, IC01096, IC01097, IC01098, IC01110, IC01111, IC01118, IC01119, IC01120, IC01132, IC01133, IC01134, IC01135, IC01136, IC01137, IC01147, IC01148, IC01149, IC01158, IC01159, IC01160, IC01171, IC01172, IC01181, IC01193, IC01194, IC01195, IC01196, IC01223, IC01224, IC01247Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154 Part 397010 Lot: IC01099, IC01108, IC01109, IC01112, IC01121, IC01138, IC01139, IC01140, IC01141, IC01151, IC01152, IC01155, IC01156, IC01157, IC01173, IC01174, IC01191, IC01192, IC01197, IC01210, IC01216, IC01219, IC01225, IC01226, IC01250, IC01251, IC01263, IC01266, IC01301 Part 397015 Lot: IC01113, IC01122, IC01124, IC01125, IC01142, IC01143, IC01144, IC01145, IC01146, IC01169, IC01170, IC01177, IC01178, IC01185, IC01186, IC01187, IC01206, IC01207, IC01208, IC01209, IC01217, IC01218, IC01221, IC01222, IC01265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2054-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2054-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code GXP

K060763Class IIStryker Injectable CementStryker / cleared 2006-09-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)