FDA Devices recall · Reported February 4, 2015
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
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 alter…
Synthes, Inc. recalled 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be … - a moderate-severity action.
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be … was recalled by Synthes, Inc. in February 4, 2015. Reason: Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and br…. Check the official notice for the remedy. Verify recall #Z-1021-2015 with the FDA Devices before acting.
The recall
Synthes, Inc. issued this moderate-severity FDA Devices recall-Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and br….
- Moderate
- severity level
- 973 units
- affected scope
- Class II
- classification
- February 4, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1021-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1021-2015) was formally reported on February 4, 2015, with the manufacturer initiating the action on December 15, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes, Inc. is listed as the recalling firm, operating out of West Chester, PA. Federal records list the affected scope as 973.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide Distribution -- US and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1021-2015 |
| Date reported | February 4, 2015 |
| Date initiated | December 15, 2014 |
| Recalling firm | Synthes, Inc. |
| Firm location | West Chester, PA |
| Affected scope | 973 |
| Distribution | Worldwide Distribution -- US and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1021-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026