Drug recall
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
FDA recall event 80131 · Class II · Stryker GmbH
Key facts
| Event ID | 80131 |
|---|---|
| Recall numbers | Z-2393-2018, Z-2394-2018, Z-2395-2018, Z-2396-2018, Z-2397-2018, Z-2398-2018, Z-2399-2018, Z-2400-2018, Z-2401-2018, Z-2402-2018, Z-2403-2018, Z-2404-2018 and 4 more |
| Recalling firm | Stryker GmbH |
| Product type | Devices |
| Products | Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S, Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S, Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S, Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S, Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S and 11 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 27, 2018 |
| Report date | Jul 18, 2018 |
| Termination date | May 21, 2020 |
| City | Selzach |
| Country | Switzerland |
| FEI number | 3002807830 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: