Recall Z-1250-2018— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1250-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-09

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2017-11-09, terminated 2019-04-16. It names one FDA 510(k) clearance: K032945. Product: 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.. Reason: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-11-09
Terminated: 2019-04-16
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K032945 — SIMPLEX XStryker Corp.·cleared 2004-05-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.

Reason for recall

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Data sourced from openFDA. This site is unofficial and independent of the FDA.