Reported Feb 4, 2015 · Terminated
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting…
Synthes, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
- Lot codes and dates
- Sold Lot Numbers5775823; Manufacturing Lot Number
84 of 84 codes
452083045193394528112452751045275094528678452951745324284542201454710645471074548231455220245522034562899456683545727744572775457875445810354593516473893847682384805320480532148056224805623481435148696784871808488049348804954888588491521249152134935249493525049643194964324497322950212315021232502123350366505036651505685550561545056856507956350795645079565507953850906755090677510535251446955144697514469651619695161970
85 of 85 codes
A7LA49A7LA48A7LA51A7LA50A7LA50A7LA51A7LA51A7LA47A7MA03A7MA05A7MA05A7MA05A7MA06A7MA06A7MA09A7MA10A7MA11A7MA11A7MA13A7MA14A7MA18A7NA08A7NA08A7NA25A7NA25A7NA25A7NA25A7NA25A7NA40A7NA41A7NA43A7NA43A7NA43A7NA43A7NA51A7NA52A7NA51A7OA09A7OA09A7OA09A7OA21A7OA21A7OA21A7OA24A7OA24A7OA30A7OA29A7OA33A7OA29A7OA35A7OA35A7OA36A7OA38A7OA38A7OA41A7OA50A7OA50A7OA50A7OA51A7OA51
- Sold Lot Numbers
- Amount recalled
- 973
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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