Recall Z-0168-2021
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 RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
Codes / lots: Batch Numbers: 2014657 2013922 2013943 2013986 2016204 2016148 2016205 2016243 2017825 2017855 2017857 2018810 2018751 2018750 2021052 2020060 2020061 2020062 2021397 2021459 2021463 2023236 2023281 2023282 2023341 2024779 2024736 2024781 2024825 2024827 2025052 2025053 2024829 2025199 2025201 2025430 2027466 2027433 2027499 2029348 2029349 2029397 2029396 2027404 2030950 2030951 2031020 2031021 2031154 2031155 2032822 2032823 2033289 2033288 2034424 2034425 2034497 2035498 2035499 2035535 2035536 2034496 2036303 2036304 2034494 2034495 2036723 2037189 2037149 2037150 2038326 2038327 2038468 2038467 2038802 2039670 2039262 2039450 2039608 2040107 2041200 2041069 2042595 2042596 2042775 2042776 2045868 2048386 2048387 2048388 2048389 2049911 2049912 2049907 2049909 2049910 2049908 2052168 2053908 2053909 2053910 2053911 2056075 2056076 2056077 2056078 2056079 2056425
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-0168-2021
- 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 |