Recall Z-2401-2018
Stryker GmbH · initiated April 27, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Femoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238S
Codes / lots: GTIN: 04546540200693; Lot code: K08327F
Reason for recall
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
FDA-determined cause: Employee error
Action taken
Urgent Product Recall letters dated 4/27/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 6. Branches/Agencies: Return all affected products available at your location to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 PR 1774317 Event 6020 7. Hospitals/Branches/Agencies: Complete and sign the enclosed Business Reply Form and fax to 1-888-230-2125 or to Email: strykerortho6020@stericycle.com
Details
- Recall number
- Z-2401-2018
- Initiated
- April 27, 2018
- Terminated
- May 21, 2020
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Distribution
- The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
- Recalling firm
- Stryker GmbH, Selzach
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2393-2018 Class II | Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2394-2018 Class II | Femoral Nail, A/R T2 Femur 10x320 mm, Product Number 18251032SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2395-2018 Class II | Femoral Nail, A/R T2 Femur 10x340 mm, Product Number 18251034SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2396-2018 Class II | Femoral Nail, A/R T2 Femur 12x360 mm, Product Number 18251236SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2397-2018 Class II | Femoral Nail, A/R T2 Femur 15x240 mm, Product Number 18251524SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2398-2018 Class II | Femoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2399-2018 Class II | Femoral Nail, A/R, R1500 T2 Femur 12x300 mm, Product Number 18281230SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2400-2018 Class II | Femoral Nail, A/R, R1500 T2 Femur 12x360 mm, Product Number 18281236SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2402-2018 Class II | Femoral Nail, LEFT T2 GTN 10x360 mm, Product Number 18501036SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2403-2018 Class II | Femoral Nail, LEFT T2 GTN 12x360 mm, Product Number 18501236SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2404-2018 Class II | Femoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2405-2018 Class II | Femoral Nail, RIGHT T2 GTN 9x320 mm, Product Number 18510932SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2406-2018 Class II | Femoral Nail, RIGHT T2 GTN 14x460 mm, Product Number 18511446SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2407-2018 Class II | Ankle Arthrodesis Nail, right T2 Ankle 10x300mm, Product Number 18191030SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |
| Z-2408-2018 Class II | Ankle Arthrodesis Nail, right T2 Ankle 11x300mm, Product Number 18191130SThe manufacturer has discovered that potentially out-of-specification products may have left the factory.… | 04/27/2018Terminated |