Recall Z-2045-2017
Arthrex, Inc. · initiated March 24, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Codes / lots: 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
Reason for recall
Some eyelets broke from SwiveLock Anchor on insertion.
FDA-determined cause: Under Investigation by firm
Action taken
On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact Complaints@Arthrex.comor 866-267-9138
Details
- Recall number
- Z-2045-2017
- Initiated
- March 24, 2017
- Terminated
- November 4, 2019
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- 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)
- Recalling firm
- Arthrex, Inc., Naples, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2041-2017 Class II | Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2042-2017 Class II | Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2043-2017 Class II | Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2044-2017 Class II | Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |
| Z-2046-2017 Class II | Anthrex SpeedBridge Implant System with PEEK SwiveLock Self PunchingSome eyelets broke from SwiveLock Anchor on insertion. | 03/24/2017Terminated |