Recall Z-2497-2019— Aesculap Implant Systems LLC

Name: FDA recall Z-2497-2019
Creator: U.S. Food and Drug Administration
Published: 2019-08-07

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2019-08-07, terminated 2020-05-12. It names one FDA 510(k) clearance: K093075. Product: CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.. Reason: possibility of the sterility batch being insufficiently sterilized.

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2019-08-07
Terminated: 2020-05-12
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K093075 — ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENTAragon Surgical, Inc.·cleared 2010-01-21

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

CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.

Reason for recall

possibility of the sterility batch being insufficiently sterilized

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