1 — Class II medical device recall Z-1246-2018
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2018-04-04, distributed in DC. Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
| Recall number | Z-1246-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2017-11-09 |
| Classified | 2018-03-28 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-04-16 |
| Distributed | DC |
| Countries outside the US | AR, AU, CA, CL, ES, FR, GB, IT, JP, KR, NL |
| Quantity | 5,988 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04546540144300, 04546540861641, 04546540861764, 04546540861818 |
| Lot numbers | 17278012, 17279012, 17280012, 17282012, 17283012, 17284012, 17285012, 17286012, 17289012, 17292012 |
Product
1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.
Reason for recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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-1246-2018. 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.