Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Reported: October 20, 2021 Initiated: September 8, 2021 #Z-0104-2022
Product Description
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
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.
Details
- Recalling Firm
- K2M, Inc
- Units Affected
- 23
- Distribution
- Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
- Location
- Leesburg, VA
Frequently Asked Questions
What product was recalled? ▼
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068. Recalled by K2M, Inc. Units affected: 23.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0104-2022.
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