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Terminated

5.5MM Arthrogarde Hip Access Cannula

FDA Recall Z-0301-2021 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeNBH
Date Initiated2020-09-21
Date Terminated2024-03-22
Product Quantity143 units

Reason for Recall

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.

Firm Action

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 [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.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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