FDA Device recall Z-2623-2015

KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem…

FDA Device
Class II
terminated
Published 2015-09-09

On 2015-09-09 the FDA classified a Class II recall of KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem… by Customed, citing recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2623-2015
Classification	Class II
Status	terminated
Initiated	2015-07-10
Published	2015-09-09
Last updated	2026-09-13 11:53 UTC
Company	Customed
Distribution	PR

Product

KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Reason

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Identifiers

code_info	Code:9002123 Lots: 141015700 exp. 2/28/16 141216296 exp. 12/31/15 150116519 exp. 1/31/16 150217384 exp. 2/28/16 1… Code:9002123 Lots: 141015700 exp. 2/28/16 141216296 exp. 12/31/15 150116519 exp. 1/31/16 150217384 exp. 2/28/16 150317796 exp. 3/31/16 150318119 exp. 4/30/16 150318120 exp. 5/31/16 150418346 exp. 5/31/16 150619248 exp. 6/30/16

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2623-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.