Synthes, Inc. 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
Brand
Synthes, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Synthes, Inc. is recalling 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for be due to 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, surgica. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 12, 2026