CLASS II Device recall · Reported 6 Apr 2022 · FDA Enforcement Report
EasyFuse Dynamic Compression System Instrument Pack recalled
Wright Medical Technology is recalling EasyFuse Dynamic Compression System Instrument Pack, distributed in Florida, North Carolina, Ohio, Texas. The recall was initiated on 10 Mar 2022 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-0853-2022
- FDA event ID
- 89739
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2022
- FDA classified
- 31 Mar 2022
- Reported
- 6 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Mar 2022 | Recall initiated by company | |
| 31 Mar 2022 | Classified by FDA | +21 days |
| 6 Apr 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
EasyFuse Dynamic Compression System Instrument Pack
Where it was distributed
US distribution to Florida, North Carolina, Ohio, and Texas
Questions about this recall
Why was it recalled?
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
Which lots are affected?
Model Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)
Where was it sold?
US distribution to Florida, North Carolina, Ohio, and Texas
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 26 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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