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

Lot, batch or date codesModel Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)

Quantity recalled176 packs

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

Florida North Carolina Ohio Texas

Questions about this recall

Is EasyFuse Dynamic Compression System Instrument Pack recalled?

Yes. Wright Medical Technology recalled EasyFuse Dynamic Compression System Instrument Pack on 10 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-0853-2022.

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 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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