Reported Sep 4, 2013 · Terminated
Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc),…
Stryker Craniomaxillofacial Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Craniomaxillofacial Division · 750 Trade Centre Way · Portage, MI · 49002-0482
Is this the product you have?
- 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.
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published 79-43905Lot: IC01116, IC01130, IC01204, IC01233, IC01238 79-43910Lot: 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 79-43015Lot: IC01087, IC01090, IC01091, IC01153, IC01154, IC01163, IC01164, IC01165, IC01179, IC01183, IC01184, IC01201, IC01202, IC01203, IC01231, IC01243, IC01244, IC01248, IC01249, IC01261, IC01264 397003Lot: IC01100, IC01114, IC01161, IC01162, IC01182, IC01211, IC01212, IC01227, IC01228, IC01241, IC01242, IC01252, IC01253, IC01254, IC01267 397005Lot: IC01092, IC01101, IC01102, IC01103, IC01104, IC01105, IC01106, IC01107, IC01115, IC01127, IC01131, IC01205, IC01220, IC01232, IC01234 — 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 397010Lot: IC01087, IC01090, IC01091, IC01153, IC01154 397015Lot: 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 — 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 - Amount recalled
- 12,719
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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