Recall Z-1011-2022 ยท HTY Pin, Fixation, Smooth
Stryker GmbH
Smart Toe II Intramedullary Arthrodesis Implant
| Date | Mar 28, 2022 |
| Status | Open, Classified |
| Reason | The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity". |
| Root cause | Process control |
| Action | A recall notice was disseminated via mail on 03/28/2022 delivered by FedEx Priority One to Hospital/Medical Facilities and Distributor/Subsidiary via email where inventory records indicate the product was distributed. They are requested to immediately quarantine all recalled products they have and return all affected product to local Stryker GmbH distribution site as soon as possible. If they have further distributed the affected product, they are asked to notify the applicable parties at once about this recall and Stryker will work directly with them to collect the recalled items. |
| Quantity | 246 implants |
| Distribution | Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112197 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER Memometal Technologies, Nov 17, 2011 |