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Devices
Device Recall Arthrex SwiveLock Anchors
Model / Serial
Unique Device Identifier: 00888867027329 Batch Number: 10072597 - Expiration Date 10/31/2018 Batch Number: 10074288 - Expiration Date 10/31/2018 Batch Number: 10076753 - Expiration Date 10/31/2018 Batch Number: 10076852 - Expiration Date 10/31/2018 Batch Number: 10081420 - Expiration Date 11/30/2018 Batch Number: 10075965 - Expiration Date 10/31/2018 Batch Number: 10077252 - Expiration Date 10/31/2018 Batch Number: 10084027 - Expiration Date 12/31/2017
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
Product Description
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Manufacturer
Arthrex, Inc.
1 Event
Recall of Device Recall Arthrex SwiveLock Anchors
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Manufacturer
Arthrex, Inc.
Manufacturer Address
Arthrex, Inc., 1370 Creekside Blvd, Naples FL 34108-1945
Manufacturer Parent Company (2017)
Arthrex, Inc.
Source
USFDA
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Device Recall Arthrex SwiveLock Anchors
Model / Serial
Unique Device Identifier: 00888867026766 Batch Number: 1078259 Expiration Date 11/30/2018
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
Product Description
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Manufacturer
Arthrex, Inc.
Device Recall Arthrex SwiveLock Anchors
Model / Serial
Unique Device Identifier: 00888867026803 Batch Number: 10078258 Expiration Date 12/01/2021
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
Product Description
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Manufacturer
Arthrex, Inc.
Device Recall Arthrex SwiveLock Anchors
Model / Serial
Unique Device Identifier: 00888867026865 Batch Number: 10072425 - Expiration Date 10/31/2018 Batch Number: 10073992 - Expiration Date 10/31/2018 Batch Number: 10077133 - Expiration Date 10/31/2018 Batch Number: 10078077 - Expiration Date 11/30/2018 Batch Number: 10078340 - Expiration Date 11/30/2018 Batch Number: 10075792 - Expiration Date 10/31/2018
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
Product Description
Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Manufacturer
Arthrex, Inc.
Device Recall Arthrex SwiveLock Anchors
Model / Serial
Unique Device Identifier: 00888867026926 Batch Number: 10072597 - Expiration Date 10/31/2021
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
Product Description
Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Manufacturer
Arthrex, Inc.
Device Recall Arthrex SwiveLock Anchors
Model / Serial
Unique Device Identifier: 00888867160231 Batch Number: 10070003 - Expiration Date 9/30/2021
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
Product Description
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Manufacturer
Arthrex, Inc.
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