Recall StatusOpen, Classified
Date Initiated2020-07-16
Product Quantity1,845 units
Reason for Recall
Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
Firm Action
On July 16th the firm send a letter to its consignees with the following instructions:
Required Actions:
1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately.
a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete.
b. Include the customers account number and name in the table below.
2. Please provide a copy of the attached Physician Communication to the surgical staff.
3. If you have no product to return, please put an X in the appropriate location below.
4. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below.
5. Complete the remainder of the form, sign and send to
[email protected].
Please Note even if you have no product to return, this form must be completed, signed and returned.
6. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number.
If you have any questions or concerns regarding this recall please contact
[email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Domestic Distribution: AL, LA ,MN, KY, AR, MN, GA, TX, WI, NJ, NC, CT, NY, OH, IA, IN, NC, MA, SC, NV, CT, WV, NY, OH, MN, MI, SC, TN, FL, AZ, PA and MO.
International Distribution:
Austria, Belgium, China, Canada, Switzerland, Colombia, Cyprus, Check Republic, Denmark, Spain, France, Great Britain, Greece, Hungary, India, Italy, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Russia, Sweden, Slovenia, Turkey and Ukraine.
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.