Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2017 - (Recall #: Z-1112-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

SwishTapered Implant

Product Classification:

Class II

Date Initiated: December 12, 2016

Date Posted: February 8, 2017

Recall Number: Z-1112-2017

Event ID: 76111

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.

Status: Terminated

Product Quantity: 17

Code Information:

933308 Lot # 73241

Distribution Pattern:

U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated