Z-0635-2022Class II

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient...

Name: Z-0635-2022 Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient...
Creator: Smith & Nephew, Inc.
Published: 2021-12-14
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2021-12-14 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures... on 2021-12-14. FDA classified it as Class II and gives the reason as "Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process". 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-0635-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-14
Posted: 2022-02-10
Recalling firm: Smith & Nephew, Inc.
Product: Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Product code: KQZ Component, Traction, Non-Invasive
Reason for recall: Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Smith & Nephew issued Urgent Medical Device (R-2021-11) on 12/14/21 to Hospitals via FedX, to Sales rep. and Foreign Distributor via email.. An updated letter issued 1/14/22 to correct a batch number clerical error. Letters state reason for recall, health risk and action to take: 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 customer s account number and name in the table below. 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]. 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: 271 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.
Product codes and lots: Lot Numbers: 50971615, 50971617 & 50967788

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0635-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0635-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-10

Product code KQZ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)