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Tibial knee prosthesis recallZ-2774-2020 · Smith & Nephew, Inc. · initiated Jul 16, 2020

Class II Open, Classified All recalls posted in August 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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].

Recall details

Recall number
Z-2774-2020
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jul 16, 2020
Posted by the FDA
Aug 8, 2020
Recalling firm
Smith & Nephew, Inc.
Quantity
1,845 units
Product code
JWH
FDA submissions
K951987
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, 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.

Product description

Tibial knee prosthesis

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model: 71420164; 71420166 and 71420184  Lot Numbers: 19MT31457, 19MT31458,19MT31459, 20AT32611, 20AT32612, 20AT32613, 20AT33540, 20AT33541, 20AT33542, 20AT33543, 20AT33544, 20AT33545, 20AT33546, 20AT33547, 20AT33548, 20AT33569, 20AT33570, 20AT33571, 20BT33856, 20BT33857, 20BT33858, 20BT33859, 20BT33860, 20BT33861, 20BT33862, 20BT33863, 20BT33864, 20BT33865, 20BT33866, 20BT33878, 20BT33879, 20BT33880, 20BT33881, 20BT33882, 20BT33883, 20BT33884, 20BT33885, 20BT33886, 20BT33887, 20BT33888, 20BT33889, 20BT34357, 20BT34358, 20BT34359, 20BT34360, 20BT34379, 20BT34380, 20BT34381, 20BT34382, 20BT34383, 20BT34384, 20BT34385, 20BT34386, H2008427, G1923903, G1923904, G1923905, G1923933, G1923934, G1923935, G1923936, G1923964, G1923965, G1923966, G1923967, G1923992, G1923993, G1923994, G1924450, G1924451, G1924452, G1924453, G1924480, G1924481, G1924482, G1924483, G1924512, G1924513, G1924514, G1924543, G1924544, G1924545, G1924571, G1924572, G1924573, G1925072, G1925073, G1925074, G1925075, G1925102, G1925106, G1925107, G1925108, G1925109, G1925137, G1925138, G1925139, G1925140, G1925165, G1925166, G1925167, G1925168, G1925194, G1925195, G1925622, G1925623, G1925624, G1925625, G1925651, G1925652, G1925653, G1925654, G1925682, G1925683, G1925684, G1925685, G1925712, G1925713, G1925714, G1925715, G1925741, G1925742, G1926271, G1926272, G1926273, G1926274, G1926301, G1926302.

Other devices under the same FDA submission

137 devices cleared under K951987 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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