—#183839

Product

5.5MM Arthrogarde Hip Access Cannula

FDA product code: NBH — Accessories, Arthroscopic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Model: 72201743, Lot: 50838788, 50834909,50846565, 50842905 & 50822169.

Why it was recalled

The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.

Root cause (FDA determination)

Process control

Action the firm took

On 9/21/2020 the firm send a notification 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. 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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 150 Minuteman Rd, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Domestic Distribution: CA, CO, CT, GA, IA, IL, IN, MD, MO, NC, NY, OH, PA, SC, TN, TX, WA, WI, WV. International Distribution: AU, BR, CA, CL, CN, CO, DE, ES, GB, HK, KR, PA, PT, TW.

Timeline

Recall initiated: 2020-09-21
Terminated: 2024-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.