—#183777

Product

TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602

FDA product code: MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K151105
Affected lot / code info: Batch Numbers: 2013151 2013152 2013903 2016145 2017808 2018788 2019884 2019885 2025277 2027457 2031003 2031002 2031054 2031055 2033509 2033508 2034401 2038771 2042570 2042752 2048296 2049809 2050955 2053788 2056330 2056872

Why it was recalled

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Smith & Nephew issued Urgent Medical Device Recall letter (R-2020-19) FSN on September 9, 2020 via email or overnight mail to customers that received affected products. Letter states reason for recall, health risk, and action to take: 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. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

Timeline

Recall initiated: 2020-09-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183777. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.