LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, T
Summary
The FDA issued a Class II for LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine La by Alphatec Spine, Inc.. Reason: Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the des.
Details
Source
Device Recall
External ID
Z-2475-2023
Action Date
2023-09-06
Status
Ongoing
Category
device
Product Description
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
Lot/Code Info: UDI-DI: 00190376228037, Lot: EM50715
Quantity Affected: 29
Reason for Recall
Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
Distribution
US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-07
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Alphatec Spine, Inc. has 41 FDA actions in our database, including 6 recalls and 35 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alphatec Spine, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alphatec Spine, Inc. have FDA actions?
Alphatec Spine, Inc. has 41 FDA actions in our database, including 6 recalls and 35 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2475-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29