Recall Z-0171-2021
Smith & Nephew, Inc. · initiated September 9, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
Codes / lots: Batch Numbers: 2011426 2011425 2011427 2014000 2014001 2016191 2016231 2016190 2017773 2017813 2017845 2018741 2018798 2018852 2019891 2019890 2020050 2021455 2021497 2021545 2023183 2023182 2023271 2024718 2024720 2024722 2027219 2027436 2027406 2029150 2029352 2029399 2030953 2030954 2031092 2031093 2031157 2031158 2032824 2032825 2033399 2033398 2033538 2033537 2035454 2035455 2035540 2035541 2036290 2036696 2037152 2038469 2038804 2038805 2039452 2039453 2039454 2039455 2041421 2041071 2041072 2041073 2041074 2042598 2042779 2042778 2045871 2045872 2045873 2045874 2045875 2044895 2046745 2048396 2048397 2048398 2048401 2048402 2048403 2049922 2049923 2049917 2049918 2048399 2049919 2049920 2049921 2051017 2051018 2051019 2052178 2052181 2052179 2052180 2052182 2052183 2053917 2053918 2053919 2053920 2056083 2053915 2056082 2048400 2056429 2056430 2056431 2057399 2057400 2057401
Reason for recall
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
FDA-determined cause: Equipment maintenance
Action taken
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.
Details
- Recall number
- Z-0171-2021
- Initiated
- September 9, 2020
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Quantity
- 263,874 (total)
- Distribution
- 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
- Recalling firm
- Smith & Nephew, Inc., Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0136-2021 Class II | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0137-2021 Class II | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0138-2021 Class II | TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0139-2021 Class II | TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0140-2021 Class II | TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0141-2021 Class II | TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0142-2021 Class II | TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0143-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0144-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0145-2021 Class II | ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0146-2021 Class II | BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0147-2021 Class II | RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0148-2021 Class II | OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0149-2021 Class II | OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0150-2021 Class II | OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0151-2021 Class II | OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0152-2021 Class II | OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0153-2021 Class II | OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0154-2021 Class II | OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0155-2021 Class II | TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0156-2021 Class II | TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0157-2021 Class II | TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0158-2021 Class II | TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0159-2021 Class II | TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0160-2021 Class II | TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0161-2021 Class II | TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0162-2021 Class II | TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0163-2021 Class II | TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0164-2021 Class II | TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number:…Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |
| Z-0165-2021 Class II | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |