Medtronic Xomed, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0734-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Lamicel 20PK 5MM INTL

Product Classification:

Class II

Date Initiated: November 13, 2019

Date Posted: January 1, 2020

Recall Number: Z-0734-2020

Event ID: 84332

Reason for Recall:

Routine sterilization dose does not meet the required Sterility Assurance Level.

Status: Ongoing

Product Quantity: 307 packs; 6140 units

Code Information:

UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918

Distribution Pattern:

Affected product was only distributed in Japan.

Voluntary or Mandated:

Voluntary: Firm initiated