PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported March 23, 2016

Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX CANN SCREW 7.0MM 114603000 MAGNA-FX CANN SCREW 7.0MM 114603500 MAGNA-FX CANN SCREW 7.0MM 114604000 MAGNA-FX CANN SCREW 7.0MM 114604032 MAGNA-FX CANN SCREW 7.0MM 114604500 MAGNA-FX CANN SCREW 7.0MM 114604532 MAGNA-FX CANN SCREW 7.0MM 114604599 MAGNA-FX CANN SCREW 7.0MM 114605000 MAGNA-FX CANN SCREW 7.0MM 114605032 MAGNA-FX CANN SCREW 7.0MM 11460

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Recall #
Z-1142-2016
Affected scope
4335
Initiated
January 11, 2016
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Zimmer Manufacturing B.v. recalled Product 44 consists of all product under product code: HWC and same usage: Item no: 1… - a moderate-severity action.

Product 44 consists of all product under product code: HWC and same usage: Item no: 1… was recalled by Zimmer Manufacturing B.v. in March 23, 2016. Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Au…. Check the official notice for the remedy. Verify recall #Z-1142-2016 with the FDA Devices before acting.

The recall

Zimmer Manufacturing B.v. issued this moderate-severity FDA Devices recall-As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Au….

Moderate
severity level
4K units
affected scope
Class II
classification
March 23, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1142-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 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

Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX CANN SCREW 7.0MM 114603000 MAGNA-FX CANN SCREW 7.0MM 114603500 MAGNA-FX CANN SCREW 7.0MM 114604000 MAGNA-FX CANN SCREW 7.0MM 114604032 MAGNA-FX CANN SCREW 7.0MM 114604500 MAGNA-FX CANN SCREW 7.0MM 114604532 MAGNA-FX CANN SCREW 7.0MM 114604599 MAGNA-FX CANN SCREW 7.0MM 114605000 MAGNA-FX CANN SCREW 7.0MM 114605032 MAGNA-FX CANN SCREW 7.0MM 114605099 MAGNA-FX CANN SCREW 7.0MM 114605500 MAGNA-FX CANN SCREW 7.0MM 114605532 MAGNA-FX CANN SCREW 7.0MM 114605599 MAGNA-FX CANN SCREW 7.0MM 114606000 MAGNA-FX CANN SCREW 7.0MM 114606032 MAGNA-FX CANN SCREW 7.0MM 114606099 MAGNA-FX CANN SCREW 7.0MM 114606500 MAGNA-FX CANN SCREW 7.0MM 114606532 MAGNA-FX CANN SCREW 7.0MM 114606599 MAGNA-FX CANN SCREW 7.0MM 114607000 MAGNA-FX CANN SCREW 7.0MM 114607032 MAGNA-FX CANN SCREW 7.0MM 114607500 MAGNA-FX CANN SCREW 7.0MM 114607532 MAGNA-FX CANN SCREW 7.0MM 114607599 MAGNA-FX CANN SCREW 7.0MM 114608000 MAGNA-FX CANN SCREW 7.0MM 114608032 MAGNA-FX CANN SCREW 7.0MM 114608099 MAGNA-FX CANN SCREW 7.0MM 114608500 MAGNA-FX CANN SCREW 7.0MM 114608532 MAGNA-FX CANN SCREW 7.0MM 114608599 MAGNA-FX CANN SCREW 7.0MM 114609000 MAGNA-FX CANN SCREW 7.0MM 114609032 MAGNA-FX CANN SCREW 7.0MM 114609099 MAGNA-FX CANN SCREW 7.0MM 114609500 MAGNA-FX CANN SCREW 7.0MM 114609532 MAGNA-FX CANN SCREW 7.0MM 114609599 MAGNA-FX CANN SCREW 7.0MM 114610000 MAGNA-FX CANN SCREW 7.0MM 114610032 MAGNA-FX CANN SCREW 7.0MM 114610099 MAGNA-FX CANN SCREW 7.0MM 114610500 MAGNA-FX CANN SCREW 7.0MM 114610532 MAGNA-FX CANN SCREW 7.0MM 114610599 MAGNA-FX CANN SCREW 7.0MM 114611000 MAGNA-FX CANN SCREW 7.0MM 114611032 MAGNA-FX CANN SCREW 7.0MM 114611099 MAGNA-FX CANN SCREW 7.0MM 114611500 MAGNA-FX CANN SCREW 7.0MM 114611532 MAGNA-FX CANN SCREW 7.0MM 114611599 MAGNA-FX CANN SCREW 7.0MM 114612000 MAGNA-FX CANN SCREW 7.0MM 114612032 MAGNA-FX CANN SCREW 7.0MM 114612500 MAGNA-FX CANN SCREW 7.0MM 114612599 MAGNA-FX CANN SCREW 7.0MM 114613000 MAGNA-FX CANN SCREW 7.0MM 114613099 MAGNA-FX CANN SCREW 7.0MM 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 511007045 MGII KNEE SLF-TAP BONE ST 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MINI MAGNA-FX CANN SCREW 114204036 MINI MAGNA-FX CANN SCREW 114204040 MINI MAGNA-FX CANN SCREW 114204044 MINI MAGNA-FX CANN SCREW 114204048 MINI MAGNA-FX CANN SCREW 114204055 MINI MAGNA-FX CANN SCREW 114204065 MINI MAGNA-FX CANN SCREW 114204124 MINI MAGNA-FX CANN SCREW 114204126 MINI MAGNA-FX CANN SCREW 114204128 MINI MAGNA-FX CANN SCREW 114204130 MINI MAGNA-FX CANN SCREW 114204132 MINI MAGNA-FX CANN SCREW 114204134 MINI MAGNA-FX CANN SCREW 114204136 MINI MAGNA-FX CANN SCREW 114204138 MINI MAGNA-FX CANN SCREW 114204140 MINI MAGNA-FX CANN SCREW 114204142 MINI MAGNA-FX CANN SCREW 114204144 MINI MAGNA-FX CANN SCREW 114204146 MINI MAGNA-FX CANN SCREW 114204148 MINI MAGNA-FX CANN SCREW 114204150 MINI MAGNA-FX CANN SCREW 114204155 MINI MAGNA-FX CANN SCREW 114204160 MINI MAGNA-FX CANN SCREW 114204165 MINI MAGNA-FX CANN SCREW 114204170 MINI MAGNA-FX CANN SCREW 114205012 MINI MAGNA-FX CANN SCREW 114205016 MINI MAGNA-FX CANN SCREW 114205020 MINI MAGNA-FX CANN SCREW 114205024 MINI MAGNA-FX CANN SCREW 114205028 MINI MAGNA-FX CANN SCREW 114205032 MINI MAGNA-FX CANN SCREW 114205036 MINI MAGNA-FX CANN SCREW 114205040 MINI MAGNA-FX CANN SCREW 114205044 MINI MAGNA-FX CANN SCREW 114205048 MINI MAGNA-FX CANN SCREW 114205055 MINI MAGNA-FX CANN SCREW 114205065 MINI MAGNA-FX CANN SCREW 114205124 MINI MAGNA-FX CANN SCREW 114205126 MINI MAGNA-FX CANN SCREW 114205128 MINI MAGNA-FX CANN SCREW

Reason for recall

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1142-2016
Date reported March 23, 2016
Date initiated January 11, 2016
Recalling firm Zimmer Manufacturing B.v.
Firm location Mercedita, PR
Affected scope 4335
Distribution US Nationwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

4335 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1142-2016) 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.

Frequently Asked Questions

What product was recalled? ▼
Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX CANN SCREW 7.0MM 114603000 MAGNA-FX CANN SCREW 7.0MM 114603500 MAGNA-FX CANN SCREW 7.0MM 114604000 MAGNA-FX CANN SCREW 7.0MM 114604032 MAGNA-FX CANN SCREW 7.0MM 114604500 MAGNA-FX CANN SCREW 7.0MM 114604532 MAGNA-FX CANN SCREW 7.0MM 114604599 MAGNA-FX CANN SCREW 7.0MM 114605000 MAGNA-FX CANN SCREW 7.0MM 114605032 MAGNA-FX CANN SCREW 7.0MM 114605099 MAGNA-FX CANN SCREW 7.0MM 114605500 MAGNA-FX CANN SCREW 7.0MM 114605532 MAGNA-FX CANN SCREW 7.0MM 114605599 MAGNA-FX CANN SCREW 7.0MM 114606000 MAGNA-FX CANN SCREW 7.0MM 114606032 MAGNA-FX CANN SCREW 7.0MM 114606099 MAGNA-FX CANN SCREW 7.0MM 114606500 MAGNA-FX CANN SCREW 7.0MM 114606532 MAGNA-FX CANN SCREW 7.0MM 114606599 MAGNA-FX CANN SCREW 7.0MM 114607000 MAGNA-FX CANN SCREW 7.0MM 114607032 MAGNA-FX CANN SCREW 7.0MM 114607500 MAGNA-FX CANN SCREW 7.0MM 114607532 MAGNA-FX CANN SCREW 7.0MM 114607599 MAGNA-FX CANN SCREW 7.0MM 114608000 MAGNA-FX CANN SCREW 7.0MM 114608032 MAGNA-FX CANN SCREW 7.0MM 114608099 MAGNA-FX CANN SCREW 7.0MM 114608500 MAGNA-FX CANN SCREW 7.0MM 114608532 MAGNA-FX CANN SCREW 7.0MM 114608599 MAGNA-FX CANN SCREW 7.0MM 114609000 MAGNA-FX CANN SCREW 7.0MM 114609032 MAGNA-FX CANN SCREW 7.0MM 114609099 MAGNA-FX CANN SCREW 7.0MM 114609500 MAGNA-FX CANN SCREW 7.0MM 114609532 MAGNA-FX CANN SCREW 7.0MM 114609599 MAGNA-FX CANN SCREW 7.0MM 114610000 MAGNA-FX CANN SCREW 7.0MM 114610032 MAGNA-FX CANN SCREW 7.0MM 114610099 MAGNA-FX CANN SCREW 7.0MM 114610500 MAGNA-FX CANN SCREW 7.0MM 114610532 MAGNA-FX CANN SCREW 7.0MM 114610599 MAGNA-FX CANN SCREW 7.0MM 114611000 MAGNA-FX CANN SCREW 7.0MM 114611032 MAGNA-FX CANN SCREW 7.0MM 114611099 MAGNA-FX CANN SCREW 7.0MM 114611500 MAGNA-FX CANN SCREW 7.0MM 114611532 MAGNA-FX CANN SCREW 7.0MM 114611599 MAGNA-FX CANN SCREW 7.0MM 114612000 MAGNA-FX CANN SCREW 7.0MM 114612032 MAGNA-FX CANN SCREW 7.0MM 114612500 MAGNA-FX CANN SCREW 7.0MM 114612599 MAGNA-FX CANN SCREW 7.0MM 114613000 MAGNA-FX CANN SCREW 7.0MM 114613099 MAGNA-FX CANN SCREW 7.0MM 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 511007045 MGII KNEE SLF-TAP BONE ST 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MINI MAGNA-FX CANN SCREW 114204036 MINI MAGNA-FX CANN SCREW 114204040 MINI MAGNA-FX CANN SCREW 114204044 MINI MAGNA-FX CANN SCREW 114204048 MINI MAGNA-FX CANN SCREW 114204055 MINI MAGNA-FX CANN SCREW 114204065 MINI MAGNA-FX CANN SCREW 114204124 MINI MAGNA-FX CANN SCREW 114204126 MINI MAGNA-FX CANN SCREW 114204128 MINI MAGNA-FX CANN SCREW 114204130 MINI MAGNA-FX CANN SCREW 114204132 MINI MAGNA-FX CANN SCREW 114204134 MINI MAGNA-FX CANN SCREW 114204136 MINI MAGNA-FX CANN SCREW 114204138 MINI MAGNA-FX CANN SCREW 114204140 MINI MAGNA-FX CANN SCREW 114204142 MINI MAGNA-FX CANN SCREW 114204144 MINI MAGNA-FX CANN SCREW 114204146 MINI MAGNA-FX CANN SCREW 114204148 MINI MAGNA-FX CANN SCREW 114204150 MINI MAGNA-FX CANN SCREW 114204155 MINI MAGNA-FX CANN SCREW 114204160 MINI MAGNA-FX CANN SCREW 114204165 MINI MAGNA-FX CANN SCREW 114204170 MINI MAGNA-FX CANN SCREW 114205012 MINI MAGNA-FX CANN SCREW 114205016 MINI MAGNA-FX CANN SCREW 114205020 MINI MAGNA-FX CANN SCREW 114205024 MINI MAGNA-FX CANN SCREW 114205028 MINI MAGNA-FX CANN SCREW 114205032 MINI MAGNA-FX CANN SCREW 114205036 MINI MAGNA-FX CANN SCREW 114205040 MINI MAGNA-FX CANN SCREW 114205044 MINI MAGNA-FX CANN SCREW 114205048 MINI MAGNA-FX CANN SCREW 114205055 MINI MAGNA-FX CANN SCREW 114205065 MINI MAGNA-FX CANN SCREW 114205124 MINI MAGNA-FX CANN SCREW 114205126 MINI MAGNA-FX CANN SCREW 114205128 MINI MAGNA-FX CANN SCREW. Recalled by Zimmer Manufacturing B.v.. Units affected: 4335.
Why was this product recalled? ▼
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2016. Severity: Moderate. Recall number: Z-1142-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Methodology · Corrections · Archive as of August 2026