Stryker Part Numbers 79-43903 — Class II medical device recall Z-2054-2013
Terminated recall by Stryker Craniomaxillofacial Division, reported 2013-09-04, distributed nationwide. Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exp
| Recall number | Z-2054-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Craniomaxillofacial Division, Portage, MI, United States |
| Recall initiated | 2013-07-30 |
| Classified | 2013-08-26 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CH, DE, DK, EE, ES, FI, FR, GB, IE, IT, JO, KW, LU, LV, NL, NO, NZ, PL, PT, RO, RS, RU, SA, SE, SG, ZA |
| Quantity | 12,719 |
| Reason classes | foreign material, packaging |
| Lot numbers | 79-43910, IC01084, IC01085, IC01086, IC01087, IC01088, IC01090, IC01091, IC01092, IC01093, IC01094, IC01095, IC01096, IC01097, IC01098, IC01099, IC01100, IC01101, IC01102, IC01103, IC01104, IC01105, IC01106, IC01107, IC01108, IC01109, IC01110, IC01111, IC01112, IC01113, IC01114, IC01115, IC01116, IC01118, IC01119, IC01120, IC01121, IC01122, IC01123, IC01124 and 129 more |
| Model numbers | 397003, 397005, 397010, 397015, 79-43015, 79-43903, 79-43905, 79-43910 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2054-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.