FDAClass IISeptember 18, 2019

Caiman Disp.instr.articulat.d:12/440mm recall: Sterility Concern

CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where…

Why was Caiman Disp.instr.articulat.d:12/440mm recalled?

possibility of the sterility batch being insufficiently sterilized

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 823B

Product
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where…
Recalling firm
Aesculap Implant Systems LLC
Quantity
0
Distribution
US Nationwide distribution in the state of CA.
Recall date
September 18, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls