2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or…
Medical device recall Z-1021-2015. Published in FDA’s Enforcement Report on Feb 4, 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 Feb 4, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 973 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?
Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
973, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Sold Lot Numbers: 4520830 4519339 4528112 4527510 4527509 4528678 4529517 4532428 4542201 4547106 4547107 4548231 4552202 4552203 4562899 4566835 4572774 4572775 4578754 4581035 4593516 4738938 4768238 4805320 4805321 4805622 4805623…
Every code shown here, 1,318 characters
Sold Lot Numbers: 4520830 4519339 4528112 4527510 4527509 4528678 4529517 4532428 4542201 4547106 4547107 4548231 4552202 4552203 4562899 4566835 4572774 4572775 4578754 4581035 4593516 4738938 4768238 4805320 4805321 4805622 4805623 4814351 4869678 4871808 4880493 4880495 4888588 4915212 4915213 4935249 4935250 4964319 4964324 4973229 5021231 5021232 5021233 5036650 5036651 5056855 5056154 5056856 5079563 5079564 5079565 5079538 5090675 5090677 5105352 5144695 5144697 5144696 5161969 5161970 5191074 5196260 5229584 5229586 5229585 5229587 5253009 5256476 5256477 5262049 5267000 5276395 5278583 5283776 5283780 5353853 5360628 5367534 5367535 5370545 5388335 5370546 5388336 5765950 5775823; Manufacturing Lot Number A7LA49 A7LA48 A7LA51 A7LA50 A7LA50 A7LA51 A7LA51 A7LA47 A7MA03 A7MA05 A7MA05 A7MA05 A7MA06 A7MA06 A7MA09 A7MA10 A7MA11 A7MA11 A7MA13 A7MA14 A7MA18 A7NA08 A7NA08 A7NA25 A7NA25 A7NA25 A7NA25 A7NA25 A7NA40 A7NA41 A7NA43 A7NA43 A7NA43 A7NA43 A7NA51 A7NA52 A7NA51 A7OA09 A7OA09 A7OA09 A7OA21 A7OA21 A7OA21 A7OA24 A7OA24 A7OA30 A7OA29 A7OA33 A7OA29 A7OA35 A7OA35 A7OA36 A7OA38 A7OA38 A7OA41 A7OA50 A7OA50 A7OA50 A7OA51 A7OA51 A7PA07 A7PA08 A7OA50 A7OA51 A7PA08 A7PA07 A7PA20 A7PA21 A7PA21 A7PA21 A7PA23 A7PA23 A7PA24 A7PA25 A7PA25 A7PA39 A7PA40 A7PA41 A7PA41 A7PA42 A7PA41 A7PA42 A7PA43 A7PA47 A7PA47
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.
Worldwide Distribution -- US and Canada.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Dec 15, 2014.
- FDA classified it on Jan 28, 2015.
- FDA’s Enforcement Report published it on Feb 4, 2015.
- FDA terminated it on Aug 18, 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.