Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 25, 2020
Osteosynthesis Compression Staple EasyClip
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker GmbH recalled Osteosynthesis Compression Staple EasyClip - a moderate-severity action.
Osteosynthesis Compression Staple EasyClip was recalled by Stryker GmbH in November 25, 2020. Reason: The device has the potential to release nickel above the acceptable margin of safety in pediatric patients wh…. Check the official notice for the remedy. Verify recall #Z-0457-2021 with the FDA Devices before acting.
The recall
Stryker GmbH issued this moderate-severity FDA Devices recall-The device has the potential to release nickel above the acceptable margin of safety in pediatric patients wh….
- Moderate
- severity level
- Class II
- classification
- November 25, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0457-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0457-2021) was formally reported on November 25, 2020, with the manufacturer initiating the action on September 25, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Stryker GmbH is listed as the recalling firm, operating out of Selzach, N/A. Federal records list the affected scope as 121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US..
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US.
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0457-2021 |
| Date reported | November 25, 2020 |
| Date initiated | September 25, 2020 |
| Recalling firm | Stryker GmbH |
| Firm location | Selzach, N/A |
| Affected scope | 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 wer… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0457-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0457-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 25, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.