Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Recall Z-3000-2020 · Posted None
Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeGAT
Date Initiated2019-02-21
Date Terminated2022-08-17
Product Quantity15,559 units
Reason for Recall
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
Firm Action
On February 21, 2019, the firm sent an "Urgent Medical Device Recall Notice" via Federal Express and E-Mail to all affected consignees. In addition to providing information on the recall product the firm asked consignees to take the following actions:
1. Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately.
a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out.
2. If you have no product to return, please put an X in the appropriate location below.
3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below.
4. Complete the remainder of the form, sign and send to [email protected] or fax to 901-566-7975.
Please Note even if you have no product to return, this form must be completed, signed and returned.
5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number.
6. If you have any questions or concerns regarding this recall please contact [email protected].
Root Cause
Device Design
Distribution Pattern
US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, SC, SG, TN, TX, UT, VA, WA, WI, WV OUS: Austria, Belgium, Canada, Switzerland, Germany, Denmark, France, England, Ireland, India, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, Turkey, United Arab Emirates, South Africa)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.