Recall Z-1757-2020
Smith & Nephew, Inc. · initiated March 17, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Codes / lots: Lot Numbers: 2013889 2013916 2013955 2014296 2016197 2016198 2016232 2016233 2016234 2017395 2017761 2017818 2017819 2018639 2018801 2018855 2019841 2019893 2019992 2021327 2021390 2021391 2021499 2022264 2022265 2022266 2022267 2024809 2025064 2025065 2025165 2025169 2025343 2025386 2027398 2027429 2028620 2029251 2029252 2029253 2029254 2029295 2029296 2029297 2029298 2029337 2029338 2029339 2029340 2029386 2029387 2030937 2030938 2030939 2030940 2031077 2031078 2031079 2031080 2031145 2032812 2032813 2032814 2032815 2033272 2033273 2033387 2033388 2033389 2033390 2033391 2033517 2033518 2033519 2033520 2033521 2033522 2033523 2033524 2033525 2033526 2033527 2033528 2033664 2034417 2034418 2034482 2034483 2036298 2036299 2036704 2036705 2037123 2037124 2037125 2037171 2037176 2038315 2038316 2038449 2038452 2038785 2038786 2038787 2038788 2038919 2039245 2039247 2039436 2039437 2039438 2040097 2040098 2040099 2040100 2040101 2040727 2040728 2040729 2041051 2041052 2041053 2041054 2041055 2041194 2041195 2041196 2041197 2041198 2041780 2041781 2041782 2042582 2042583 2042584 2042763 2042764 2042765 2044884 2044885 2044886 2044887 2044888 2045848 50532035 50598665 50670645…
Reason for recall
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach.
FDA-determined cause: Package design/selection
Action taken
Smith & Nephew issued Urgent Medical Device Recall letter to International customers on March 17, 2020 and FedEx letters to US customers on March 18, 2020. 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 on the first page of this Urgent Medical Device Recall Notice, and quarantine them immediately.a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location 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 or fax to +1-901-566-7975. 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-1757-2020
- Initiated
- March 17, 2020
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 125,196 (Total)
- Distribution
- Nationwide Foreign: AE AL AR AT AU BE BM BR CA CH CL CN CO CR CZ DE DK EC EE ES FI FR GB IE IL IN IT KR LT LV MT MX NO PA PE PL PR PT QA RU SE SG TH TR XK ZA
- Recalling firm
- Smith & Nephew, Inc., Mansfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1756-2020 Class II | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901Space between the device and the packaging permits excessive movement which could potentially lead to the… | 03/17/2020Open, Classified |