Z-0457-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- September 25, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US.
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.
Distribution Pattern
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.
Code Information
All lots of the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress are affected. Exp. Date: 5 years from date of manufacturing EasyClip and EasyClip Xpress staples are available in a variety of sizes identified by product and catalog numbers. See below: Product Number Product Description EZ15-12-12 Osteosynthesis Compression Staple EasyClip 15x12x12mm EZ15-15-15 Osteosynthesis Compression Staple EasyClip 15x15x15mm EZ18-12-12 Osteosynthesis Compression Staple EasyClip 18x12x12mm EZ18-15-13 Osteosynthesis Compression Staple EasyClip 18x15x13mm EZ18-14-14 Osteosynthesis Compression Staple EasyClip 18x14x14mm EZ18-17-15 Osteosynthesis Compression Staple EasyClip 18x17x15mm EZ18-19-17 Osteosynthesis Compression Staple EasyClip 18x19x17mm EZ20-16-16 Osteosynthesis Compression Staple EasyClip 20x16x16mm EZ20-20-20 Osteosynthesis Compression Staple EasyClip 20x20x20mm EZ25-22-22 Osteosynthesis Compression Staple EasyClip 25x22x22mm EZB10-15-13 Osteosynthesis Compression Staple EasyClip 10x15x13mm EZB10-17-15 Osteosynthesis Compression Staple EasyClip 10x17x15mm EZB10-19-16 Osteosynthesis Compression Staple EasyClip 10x19x16mm EZB10-20-17 Osteosynthesis Compression Staple EasyClip 10x20x17mm EZB12-15-13 Osteosynthesis Compression Staple EasyClip 12x15x13mm EZB10-22-20 Osteosynthesis Compression Staple EasyClip 10x22x20mm EZB12-17-15 Osteosynthesis Compression Staple EasyClip 12x17x15mm EZB12-19-16 Osteosynthesis Compression Staple EasyClip 12x19x16mm EZM08-08-08 Osteosynthesis Compression Staple EasyClip 8x8x8mm EZM10-10-10 Osteosynthesis Compression Staple EasyClip 10x10x10mm EZM12-10-10 Osteosynthesis Compression Staple EasyClip 10x10x10mm EZM12-14-14 Osteosynthesis Compression Staple EasyClip 12x14x14mm EZM12-16-16 Osteosynthesis Compression Staple EasyClip 12x16x16mm Catalog # Product EZBXP10-15-13 EasyClip Xpress 10x15x13 EZBXP12-15-13 EasyClip Xpress 12x15x13 EZMXP08-08-08 EasyClip Xpress 08x08x08 EZMXP10-10-10 EasyClip Xpress 10x10x10 EZMXP12-10-10 EasyClip Xpress 12x10x10 EZXP15-12-12 EasyClip Xpress 15x12x12 EZXP15-15-15 EasyClip Xpress 15x15x15 EZXP18-14-14 EasyClip Xpress 18x14x14 EZXP18-17-15 EasyClip Xpress 18x17x15 EZXP18-19-17 EasyClip Xpress 18x19x17 EZXP20-16-16 EasyClip Xpress 20x16x16 EZXP20-20-20 EasyClip Xpress 20x20x20 EZXP25-22-22 EasyClip Xpress 25x22x22