Z-2818-2020Class II

Single RIKKI Retractor, Catalog #71934609 -

Name: Z-2818-2020 Single RIKKI Retractor, Catalog #71934609 -
Creator: Smith & Nephew, Inc.
Published: 2020-08-03
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-08-03 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site on 2020-08-03. FDA classified it as Class II and gives the reason as "The products were improperly heat treated". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2818-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-03
Posted: 2020-08-17
Recalling firm: Smith & Nephew, Inc.
Product: Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Product code: GAD Retractor
Reason for recall: The products were improperly heat treated.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smith and Nephew issued an Urgent Medical device recall notice. It states the following: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers in 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. If you have no product to return, please put an X in the appropriate location. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes. 4. 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. 5. 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].
Quantity in commerce: 111 units
Distribution: US states: CA CO CT GA HI IL IN KY MA MD NC NY OK PA SD TN WA WI OUS countries: AE CO JP KR PL ZA
Product codes and lots: Lot Numbers: 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, 19EM21520

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2818-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2818-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-26	2020-08-17

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)