CLASS II Device recall · Reported 5 Aug 2020 · FDA Enforcement Report
MatrixNEURO Screws recalled by Synthes
Synthes is recalling MatrixNEURO Screws, distributed nationwide in the US. The recall was initiated on 18 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2698-2020
- FDA event ID
- 85899
- Recalling firm
- Synthes, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2020
- FDA classified
- 24 Jul 2020
- Reported
- 5 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 18 Jun 2020 | Recall initiated by company | |
| 24 Jul 2020 | Classified by FDA | +36 days |
| 5 Aug 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
Where it was distributed
International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
Questions about this recall
Is MatrixNEURO Screws recalled?
Yes. Synthes recalled MatrixNEURO Screws on 18 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2698-2020.
Why was it recalled?
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
Which lots are affected?
Lot # 30P6198
Where was it sold?
International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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