Osteosynthesis Compression Staple EasyClip
Medical device recall Z-0457-2021. Published in FDA’s Enforcement Report on Nov 25, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 25, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US. how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Osteosynthesis Compression Staple EasyClip
121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 2,322 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 25, 2020.
- FDA classified it on Nov 16, 2020.
- FDA’s Enforcement Report published it on Nov 25, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker GmbH, of Selzach, Switzerland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,322 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.