Recall Z-0152-2021
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
OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
Codes / lots: Batch Numbers: 2012909 2012911 2012910 2012937 2013912 2013913 2016202 2016230 2016203 2018636 2018637 2018740 2018795 2021326 2022258 2023091 2024440 2024441 2024439 2024448 2024449 2025098 2025094 2025340 2025287 2027419 2027388 2025288 2027453 2029073 2027483 2029325 2029326 2029366 2029365 2030990 2030989 2031123 2031125 2031127 2032788 2033240 2033239 2033375 2033376 2033497 2034385 2034386 2034387 2034458 2034459 2035471 2035472 2035473 2035521 2035522 2035523 2035524 2035526 2035525 2036692 2039227 2039228 2039424 2039584 2039585 2040072 2040706 2040708 2040709 2042563 2042564 2042565 2042745 2042746 2044792 2044794 2044795 2044796 2044797 2044793 2045742 2045743 2045744 2045745 2045746 2046744 2048188 2048189 2048190 2048191 2048192 2049661 2049662 2049655 2049656 2049657 2049658 2049660 2049659 2056309 2056311 2056310 2056312 2056313
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-0152-2021
- Initiated
- September 9, 2020
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- 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-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 |
| Z-0166-2021 Class II | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a… | 09/09/2020Open, Classified |