Recall Z-0457-2021 ยท JDR Staple, Fixation, Bone
Stryker GmbH
Osteosynthesis Compression Staple EasyClip
| Date | Sep 25, 2020 |
| Status | Open, Classified |
| Reason | The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used. |
| Root cause | Under Investigation by firm |
| Action | All affected customers were mailed an Urgent Medical Device Correction (UMDC) letter on 09/25/2020 that requested them to take the following actions: 1. Please inform users of this Urgent Medical Device Correction (UMDC) and forward this notice to all individuals who need to be made aware of the recall. 2. Under 21 CFR 803, manufacturers are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing soprodexpreports@stryker.com. 3. A response is |
| Quantity | 121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US. |
| Distribution | The devices were distributed nationwide throughout the US, and to countries OUS. Easy Clip devices: As of 09/04/2020, 251,566 EasyClip devices have been manufactured. 121,517 of those devices were distributed to the US, and 102,529 were distributed in countries OUS. 27,520 devices were left in the |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122113 | MEMORY METAL STAPLES, EASYCLIP Stryker Corp., Mar 12, 2013 |