Recall Z-2180-2016
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 HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 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:M0035452040; Lot Number/Expiration Date: 18760131 31-Dec-18 18760129 31-Dec-18 18832208 31-Jan-19 18832819 31-Jan-19 18831597 31-Jan-19 18760132 31-Dec-18 18760130 31-Dec-18 18852438 28-Feb-19 18905625 31-Mar-19 18939389 31-Mar-19 19032961 30-Apr-19 19032868 30-Apr-19 19037908 31-May-19 18900809 28-Feb-19 18906580 28-Feb-19 18987592 30-Apr-19 19036655 31-May-19 18971469 30-Apr-19 18986652 30-Apr-19 18875322 28-Feb-19 19047456 31-May-19 18972020 30-Apr-19 18899967 28-Feb-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-2180-2016
- 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-2161-2016 Class II | Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030…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-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 |