K2M, Inc: Medical Device Recall in 2021 - (Recall #: Z-0104-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

Product Classification:

Class II

Date Initiated: September 8, 2021

Date Posted: October 20, 2021

Recall Number: Z-0104-2022

Event ID: 88630

Reason for Recall:

Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.

Status: Terminated

Product Quantity: 23

Code Information:

Lots CCUNA, HYMJ, KNCU

Distribution Pattern:

Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated