Tibial knee prosthesis

FDA device recall Z-2774-2020 · posted 2020-08-08 · Open, Classified

Recall details

Recalling firm

Smith & Nephew, Inc.

Reason for recall

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

Action taken

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 FieldActions@smith-nephew.com. 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 FieldActions@smith-nephew.com.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

JWH

Quantity affected

1,845 units

Distribution

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,

Date initiated

2020-07-16

Date posted

2020-08-08

Location

Memphis, TN

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