Medtronic Xomed, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0735-2020)

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 10PK 10MM INTL

Product Classification:

Class II

Date Initiated: November 13, 2019

Date Posted: January 1, 2020

Recall Number: Z-0735-2020

Event ID: 84332

Reason for Recall:

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

Status: Ongoing

Product Quantity: 10 packs; 100 units

Code Information:

UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170

Distribution Pattern:

Affected product was only distributed in Japan.

Voluntary or Mandated:

Voluntary: Firm initiated