Performance Series Sagittal Blade — Class II medical device recall Z-1215-2019

Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2019-05-01, distributed nationwide. During manufacture, packaging materials for a small portion of the lot may not have been properly positioned,

Recall number	`Z-1215-2019`
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	2019-03-19
Classified	2019-04-24
Reported by FDA	2019-05-01
Terminated	2020-06-26
Distributed	Nationwide (US)
Countries outside the US	CA, FR, IT, NL
Quantity	355
Reason classes	sterility
Lot numbers	`18247037`
Model numbers	`6125-127-100`

Product

Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and orthopedic trauma procedures. The intended part of the body will be the areas associated with the above procedures. These products will be used in a fully equipped OR suite by surgeons.

Reason for recall

During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.

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-1215-2019. 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.