SwishTapered Implant
Reported: February 8, 2017 Initiated: December 12, 2016 #Z-1112-2017
Product Description
SwishTapered Implant
Reason for Recall
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 17
- Distribution
- U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
SwishTapered Implant. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 17.
Why was this product recalled? ▼
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2017. Severity: Moderate. Recall number: Z-1112-2017.
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