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Alphatec Spine, Inc.

Alphatec Spine, Inc. Recalls

All product recalls associated with Alphatec Spine, Inc..

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Recall Summary

Total Recalls

1000

Past Year

123

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2141–2160 of 2383 recalls

Alphatec Spine, Inc.: Trestle Anterior Cervical Plate 1-level assembly, Part Nu...

The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical Plate implant.

FDAAug 25, 2009Nationwide• Alphatec Spine, Inc.

GE Healthcare Integrated IT Solutions: Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 ...

Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive.

FDAAug 14, 2009Nationwide• GE Healthcare Integrated IT Solutions

TomoTherapy Incorporated: TomoTherapy Hi-Art System, Version 3.X ThomoTherapy Incor...

TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the customer pressed the Stop button on the Sta

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FDAAug 10, 2009AL, AK, AZ +37 more• TomoTherapy Incorporated

Alphatec Spine, Inc.: Alphatec Spine Solanas Titanium Pedicle Screw, Part Numbe...

Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.

FDAAug 5, 2009Nationwide• Alphatec Spine, Inc.

Linvatec Corp. dba ConMed Linvatec: MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON...

Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONL...

Fire/Burn Risk

ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: Mpower PRO6200 Single Trigger Modular Handpiece, Mpower...

There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: PRO5100, PowerPro Battery Modular Handpiece. Drill mode ...

There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo ...

ConMed has determined there is a possibility that the device may not fully retract once it is deployed.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number...

ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: PowerProMax PRO5100M Battery Single Trigger, PowerProMax...

There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

ConvaTec: Engenex Bio-Dome Easy Release Dressing Kit, XL; Product C...

Labeling: The expiration date does not appear on the product label.

FDAJul 29, 2009Nationwide• ConvaTec

ConvaTec: Engenex Cover Strip; Product Code 446471; Advanced Negati...

Labeling: The expiration date does not appear on the product label.

FDAJul 29, 2009Nationwide• ConvaTec

ConvaTec: Engenex Wound Cover; Product Code 446470; Advanced Negati...

Labeling: The expiration date does not appear on the product label.

FDAJul 29, 2009Nationwide• ConvaTec

Spacelabs Healthcare, Incorporated: Spacelabs Medical Integrated ECG Cable are supplied as pa...

The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock.

FDAJul 23, 2009Nationwide• Spacelabs Healthcare, Incorporated

ConvaTec: ConvaTec, Engenex Tunnel Dressing, for use with Engenex N...

Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.

FDAJul 13, 2009Nationwide• ConvaTec

Action Products Incorporated: Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number...

Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.

FDAJun 26, 2009Nationwide• Action Products Incorporated

Alphatec Spine, Inc.: Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Nu...

Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.

FDAMay 13, 2009Nationwide• Alphatec Spine, Inc.

Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006: Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable ...

The siderails may exhibit false latching, or unintentional lowering, or may become inoperable.

FDAApr 20, 2009Nationwide• Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006

Stellate Systems: Harmonie software in use with: Harmonie-E Long Term Monit...

The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been cleared by the Food and Drug Administration (FDA) for sale in the United States of America.

FDAApr 16, 2009Nationwide• Stellate Systems