CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report
Headless Compression Screw, Long Thread recalled
Synthes (USA) Products is recalling Headless Compression Screw, Long Thread, distributed in 7 states. The recall was initiated on 12 Sep 2018 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-0238-2019
- FDA event ID
- 81152
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2018
- FDA classified
- 24 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 12 Sep 2018 | Recall initiated by company | |
| 24 Oct 2018 | Classified by FDA | +42 days |
| 31 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
Where it was distributed
US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
Questions about this recall
Is Headless Compression Screw, Long Thread recalled?
Yes. Synthes (USA) Products recalled Headless Compression Screw, Long Thread on 12 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0238-2019.
Why was it recalled?
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Which lots are affected?
Lot Numbers: L734474
Where was it sold?
US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
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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