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Open, Classified

Osteosynthesis Compression Staple EasyClip

FDA Recall Z-0457-2021 · Posted None

Recalling FirmStryker GmbH
Recall StatusOpen, Classified
Product CodeJDR
Date Initiated2020-09-25
Product Quantity121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US.

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.

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 [email protected]. 3. A response is required, even though you may not have any physical inventory on site anymore. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form and fax a copy to 1-888-240-4294 or email to [email protected]. 5. Branches/Agencies Only: Please forward this Urgent Medical Device Correction to the individuals or organizations who have consigned product, if applicable. Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Correction Business Reply Form within 5 days. We regret any inconvenience this action may cause you and if you have any questions or concerns after reviewing the letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email [email protected]

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122113MEMORY METAL STAPLES, EASYCLIPStryker Corp. · 2013-03-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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