Recalls / —

—#199972

Product

Total Knee Pack, REF CETJ130, medical convenience kits

FDA product code

OJH — Orthopedic Tray

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

UDI/DI: 00191072179593; Lot Number: 967231

Why it was recalled

Incorrect expiration date on product.

Root cause (FDA determination)

Labeling design

Action the firm took

Owens & Minor sent an "URGENT Product Field Correction" notice on 04/17/2023 to its sole consignee by email. The notice explained the issue and requested the following actions be taken: Identify and segregate and quarantine the affected kits in inventory. Notify all end users of this action and add labels containing correct expiration to kits. The affected product is to be relabeled using the labeling template provided. Report any quality problems or adverse events associated with the products listed in this notification to PIQ@owens-minor.com. If you have any questions, contact Regulatory Affairs Manager, Global Products at 470-280-4277 or email: GM-OMRA_RECALLS@owens-minor.com.

Recalling firm

Firm

American Contract Systems, Inc.

Address

2610 Ne Industrial Dr, Ste 220, Kansas City, Missouri 64117-2648

Distribution

Distribution pattern

US Distribution to the state of: MA

Timeline

Recall initiated

2023-04-17

Posted by FDA

2023-06-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #199972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.