Osteosynthesis Compression Staple EasyClip
Reported: November 25, 2020 Initiated: September 25, 2020 #Z-0457-2021
Product Description
Osteosynthesis Compression Staple EasyClip
Reason for Recall
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.
Details
- Recalling Firm
- Stryker GmbH
- Units Affected
- 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 firm's inventory. Easy Clip Xpress devices: As of 09/04/2020, 37,371 EasyClip Xpress devices have been manufactured. 9,561 of those devices were distributed to the US, leaving 27,810 in the firm's inventory. This device is only distributed in the United States.
- Location
- Selzach, N/A
Frequently Asked Questions
What product was recalled? ▼
Osteosynthesis Compression Staple EasyClip. Recalled by Stryker GmbH. Units affected: 121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0457-2021.
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