Stryker Orthopaedics Restoration Modular Cone Body recall: Foreign Material
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone…
Why was Stryker Orthopaedics Restoration Modular Cone Body recalled?
Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No. 6278-1-019 Mod Rev 19 mm std cone trial 6278-1-021 Mod Rev 21 mm std cone trial 6278-1-023 Mod Rev 23 mm std cone trial 6278-1-025 Mod Rev 25 mm std cone trial 6278-1-027 Mod Rev 27 mm std cone trial 6278-1-029 Mod Rev 29 mm std cone trial 6278-1-031 Mod Rev 31 mm std cone trial 6278-1-119 Mod Rev 19 mm + 10 mm cone trial 6278-1-121 Mod Rev 21mm + 10 mm cone trial 6278-1-123 Mod Rev 23mm + 10 mm cone trial 6278-1 -125 Mod Rev 25 mm + 10 mm cone trial 6278-1-127 Mod Rev 27mm + 10 mm cone trial 6278-1-129 Mod Rev 29mm + 10mm cone trial 6278-1-131 Mod Rev 31mm + 10 mm cone trial 6278 -1-219 Mod Rev 19mm + 20 mm cone trial 6278-1-221 Mod Rev 21mm +20 mm cone trial 6278-1-223 Mod Rev 23mm + 20 mm cone trial 6278-1-225 Mod Rev 25mm + 20 mm cone trial 6278-1-227 Mod Rev 27mm + 20 mm cone trial 6278-1-229 Mod Rev 29mm + 20 mm cone trial 6278-1-231 Mod Rev 31mm + 20 mm cone trial 6278-1-319 Mod Rev 19mm + 30 mm cone trial 6278-1-321 Mod Rev 21mm +30 mm cone trial 6278-1-323 Mod Rev 23mm + 30 mm cone trial 6278-1-325 Mod Rev 25mm + 30 mm cone trial 6278-1-327 Mod Rev 27mm + 30 mm cone trial 6278-1-329 Mod rev 29mm +30 mm cone trial 6278-1-331 Mod Rev 31mm + 30 mm cone trial 1 single unit to each non-sterile package Numerous lots numbers please see attachment.
- Product
- Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone…
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 10, 983 units
- Distribution
- Nationwide distribution
- Recall date
- October 10, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)