Recall Z-0617-2018— Synthes USA

Name: FDA recall Z-0617-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-10

Class II · Terminated

Class II FDA medical device recall by Synthes USA, initiated 2017-08-10, terminated 2018-09-10. It names one FDA 510(k) clearance: K102722. Product: Norian Drillable Inject. Reason: The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit..

Recalling firm: Synthes USA
Classification: Class II
Status: Terminated
Initiated: 2017-08-10
Terminated: 2018-09-10
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K102722 — NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTYSynthes USA Products, LLC·cleared 2011-01-27

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

Norian Drillable Inject

Reason for recall

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

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