Recall Z-2161-2016
Stryker Neurovascular · initiated June 6, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Codes / lots: MODEL Number: M0035421030: Lot Number/Expiration Date: 18604566 30-Sep-18 18488920 31-Jul-18 18807744 31-Jan-19 18807570 31-Jan-19 18677403 31-Oct-18 18666895 31-Oct-18 18654009 31-Oct-18 18647637 31-Oct-18 18629287 31-Oct-18 18542421 31-Aug-18 18554251 31-Aug-18 18469669 30-Jun-18 18462274 30-Jun-18 18462217 30-Jun-18 18393386 30-Apr-18 18814099 31-Jan-19 18788265 31-Jan-19 18769352 31-Dec-18 18714536 30-Nov-18 18701840 30-Nov-18 18677577 30-Nov-18 18677461 30-Nov-18 18629171 31-Oct-18 18604508 30-Sep-18 18582681 30-Sep-18 18535009 31-Aug-18 18426357 30-Jun-18 18714768 30-Nov-18 18714652 30-Nov-18 18629229 31-Oct-18 18554193 31-Aug-18 18701898 30-Nov-18 18730274 30-Nov-18 18677519 30-Nov-18 18653835 31-Oct-18 18831481 31-Jan-19 18769468 31-Dec-18 18714304 30-Nov-18 18807918 31-Jan-19 18714420 30-Nov-18 18654067 31-Oct-18 18638376 31-Oct-18 18590876 30-Sep-18 18604450 30-Sep-18 18488978 31-Jul-18 18469612 30-Jun-18 18831539 31-Jan-19 18788439 31-Jan-19 18736862 31-Dec-18 18736746 30-Nov-18 18666837 31-Oct-18 18666779 31-Oct-18 18653893 31-Oct-18 18604392 30-Sep-18 18542479 31-Aug-18 18931539 31-Mar-19 18901428 28-Feb-19 19048197 31-May-19 18945290 31-Mar-19 18931771 31-Mar-19…
Reason for recall
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
FDA-determined cause: Process change control
Action taken
Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
Details
- Recall number
- Z-2161-2016
- Initiated
- June 6, 2016
- Posted by FDA
- July 11, 2016
- Terminated
- March 3, 2017
- Product code
- HCG – Device, Neurovascular Embolization
- Quantity
- 45,302 (8,188 in the U.S.) - total, all model numbers
- Distribution
- Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal…
- Recalling firm
- Stryker Neurovascular, Fremont, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2160-2016 Class II | Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2162-2016 Class II | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2163-2016 Class II | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2164-2016 Class II | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2165-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2166-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2167-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2168-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2169-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2170-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2171-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2172-2016 Class II | Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology:…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2173-2016 Class II | Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology:…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2174-2016 Class II | Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2175-2016 Class II | Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology:…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2176-2016 Class II | Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology:…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2177-2016 Class II | Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2178-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2179-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2180-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2181-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2182-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2183-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2184-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2185-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2186-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |
| Z-2187-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | 06/06/2016Terminated |