Z-0933-2021Class II

VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 -

Name: Z-0933-2021 VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 -
Creator: Smith & Nephew, Inc.
Published: 2020-12-18
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-12-18 / Terminated

FDA source

Smith & Nephew, Inc. began a recall of VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement... on 2020-12-18. FDA classified it as Class II and gives the reason as "Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0933-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-18
Posted: 2021-01-29
Terminated: 2023-05-01
Recalling firm: Smith & Nephew, Inc.
Product: VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
Product code: LOD Bone Cement
Reason for recall: Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
FDA root cause: Storage
Action: A Recall notification letter titled, "Urgent Medical Device Recall Notice" was sent to consignees on 12/18/2020 via email and FedEx. The letter instructs the consignee to follow the instructions on the attached response form. The response form provides the following instructions: "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. 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: 5190 devices
Distribution: Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.
Product codes and lots: Product Number: 71271440; Batch Number: 18LC07540

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0933-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0933-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-01-29

Product code LOD

K022688Class IIVersabond Ab Bone CementSmith & Nephew, Inc. / cleared 2004-04-29

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)