—#185086

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.

FDA product code: LOD — Bone Cement
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K022688
Affected lot / code info: Product Number: 71271440; Batch Number: 18LC07540

Why it was recalled

Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.

Root cause (FDA determination)

Storage

Action the firm took

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

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.

Timeline

Recall initiated: 2020-12-18
Terminated: 2023-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.