K2M Surgical Removal Tool Recalled for Missing Pins
K2M, Inc. is recalling 23 units of the Chesapeake Anterior Lumbar Removal Tool because units may arrive with missing pins or in disassembled condition. Pins could dislodge during surgery and enter the surgical cavity, requiring intraoperative removal or revision surgery.
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: FDA Class II recall with risk of harm (pins dislodging into surgical cavity requiring corrective surgery) but no reported illnesses or injuries. Per rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
K2M, Inc. is recalling the Chesapeake Anterior Lumbar (AL) Removal Tool, Catalog Number 2008-90068, a surgical instrument used in anterior lumbar spine procedures.
The recalled units may arrive with missing pins and/or in a disassembled state. During surgical use, pins may dislodge from the instrument and enter the surgical cavity, potentially requiring intraoperative removal or additional revision surgery.
The recall affects 23 units with lot numbers CCUNA, HYMJ, and KNCU. These units were distributed domestically to facilities in Colorado, Illinois, Louisiana, Massachusetts, Mississippi, Oklahoma, Pennsylvania, Tennessee, and Texas, and internationally to Columbia, the United Kingdom, the Netherlands, and Canada.
Healthcare facilities that received affected units should discontinue use and contact K2M, Inc. for instructions on replacement or removal of the recalled instruments.
The recalled product
- Product
- Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
- Manufacturer
- K2M, Inc
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots CCUNA
- HYMJ
- KNCU
Distribution
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