Agency classClass IIOur severity:High FDA (Devices)·Z-1441-2016·Announced 2016-04-20

Customed Knee Arthroscopy Surgical Pack Recalled for Sterilization Defects

Customed, Inc. is recalling 12 units of Knee Arthroscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a 'High' severity score (3) in the absence of reported hospitalizations or injuries, as the hazard is a theoretical risk of infection from inadequate sterilization.

Plain-English summary

Customed, Inc. is recalling 12 units of Knee Arthroscopy Surgical Packs (Catalog Number 9002123). The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile.

The affected lots are SL15177, SL15181, SL15203, and SL15223. These products were distributed only in Puerto Rico. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

Medical staff should stop using the affected surgical packs and contact Customed, Inc. for further instructions. Consumers are not directly affected as these are professional medical devices used by healthcare providers.

The recalled product

Product: Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Packs
Hazard: infection
sterilization-failure
Affected units: 12

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 100 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 100 products in this recall →

Same manufacturer · Customed, Inc

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Same hazard · infection