Synthes Inserter for Titanium Elastic Nails
Medical device recall Z-1260-2015. Published in FDA’s Enforcement Report on Mar 18, 2015.
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 Mar 18, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1550 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 Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
1550, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Number: 359.219, Sold As Lot Numbers: 4321659 4340451 4466686 4470900 5496455 5700078 5718485 5718486 5718487 1904339 3005674 3005675 3009312 3020674 3025607 3051190 3054608 3065013 3069566 3084637 3098634 3121438 3232931 3242304…
Every code shown here, 1,864 characters
Part Number: 359.219, Sold As Lot Numbers: 4321659 4340451 4466686 4470900 5496455 5700078 5718485 5718486 5718487 1904339 3005674 3005675 3009312 3020674 3025607 3051190 3054608 3065013 3069566 3084637 3098634 3121438 3232931 3242304 3262712 3301017 3325276 3382583 3410330 3430483 3493588 3504996 3524633 3619119 3626055 3659645 3706611 3797835 7505411 7565990 7601112 7619995 7670741 7675623 7727696 7774491 7810649 7845943 7874224 7896075 7979727 4796463 4826021 4911859 4911860 4969014 4971314 5066417 5042001 5066418 5090226 5090224 5106335 5123586 5162204 5123587 5162205 5162206 5162760 5181760 5181761 5227459 5236654 5258103 5420946 5422955 5455364 5455365 5507788 5525235 5485078 5492810 5545372 5555604 5569028 5611445 5611446 5611447 5641430 5670475 5641429 5657075 5657073 5670474 5700077 5700079 8114862 8214803 8326267 8424513 8476286 8541845 8608192 8608193 8768253 8973607 9275702 4389269 4537554 4594280 4594281 4825384; (Manufacturing Lot Numbers: 1095607 1095607 1121876 1121876 1641700 1806500 1811056 1811059 1813900 1904339 3005674 3005675 3009312 3020674 3025607 3051190 3054608 3065013 3069566 3084637 3098634 3121438 3232931 3242304 3262712 3301017 3325276 3382583 3410330 3430483 3493588 3504996 3524633 3619119 3626055 3659645 3706611 3797835 7505411 7565990 7601112 7619995 7670741 7675623 7727696 7774491 7810649 7845943 7874224 7896075 7979727 8000136 8002518 8002635 8002635 8004538 8004538 8005179 8006103 8006214 8006214 8006578 8006578 8007139 8007139 8007472 8007472 8008046 8008046 8008046 8008261 8009205 8009363 8009859 8012109 8012353 8012925 8013244 8014078 8014078 8014645 8014645 8015605 8015831 8016063 8016128 8016128 8016128 8016423 8016423 8016759 8017447 8017590 8017862 8017872 8018319 8114862 8214803 8326267 8424513 8476286 8541845 8608192 8608193 8768253 8973607 9275702 A8LA901 A8MA648 A8MB744 A8NA025 A8NA430)
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.
Nationwide Distribution
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Feb 3, 2015.
- FDA classified it on Mar 10, 2015.
- FDA’s Enforcement Report published it on Mar 18, 2015.
- FDA terminated it on Aug 26, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Synthes, Inc., of West Chester, PA.
- 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.”
- 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.