—#190161

Product

Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K162078
Affected lot / code info: REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743.

Why it was recalled

The labels on the packages of screws were switched.

Root cause (FDA determination)

Error in labeling

Action the firm took

The recalling firm issued letters dated 10/25/2021 on the same day via email and FedEx overnight. The letter explained the issue and the potential risk of use of the product. Required actions were listed on the enclosed response form. The actions included inspecting their inventory and quarantining the affected product immediately and returning it. Distributors or sales representatives were to notify their customers of the field action and ensure the required actions are complete.

Recalling firm

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

Distribution

Distribution pattern: Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand.

Timeline

Recall initiated: 2021-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190161. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.