Recall Z-1756-2020
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 4.5 Part Number: 72202901
Codes / lots: Lot Numbers: 2012020 2012021 2012022 2013822 2013823 2013887 2013888 2013914 2013915 2013954 2016801 2017394 2017397 2017401 2017759 2017760 2017763 2017764 2017768 2017771 2017815 2017816 2017817 2017846 2017847 2017848 2017849 2018638 2018742 2018799 2018800 2018853 2019892 2019991 2020052 2021389 2021498 2021546 2023225 2023273 2023274 2023336 2023337 2024762 2024764 2024806 2024808 2025068 2025070 2025157 2025160 2025163 2025290 2025291 2025342 2026561 2027397 2027428 2027460 2028121 2028122 2028618 2028619 2028749 2028750 2028751 2029248 2029249 2029250 2029291 2029292 2029293 2029294 2029334 2029335 2029336 2029383 2029384 2029385 2030933 2030934 2030935 2030936 2031067 2031068 2031069 2031070 2031071 2031072 2031073 2031074 2031075 2031076 2031141 2031142 2031143 2031144 2032807 2032808 2032809 2032810 2032811 2033267 2033268 2033269 2033270 2033271 2033382 2033383 2033384 2033385 2033386 2033514 2033515 2033516 2033663 2034412 2034413 2034414 2034415 2034416 2034477 2034478 2034479 2034480 2034481 2035480 2035481 2035482 2035483 2035484 2036292 2036293 2036294 2036295 2036296 2036297 2036698 2036699 2036700 2037117 2037118 2037119 2037120 2037121 2037170 2038309 2038310…
Reason for recall
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors 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-1756-2020
- 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-1757-2020 Class II | Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902Space between the device and the packaging permits excessive movement which could potentially lead to the… | 03/17/2020Open, Classified |