CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report

Turon Impaction Fixture recalled by Encore Medical

Encore Medical is recalling Turon Impaction Fixture. The recall was initiated on 9 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes101521L01, 115670L18, 128092L10, 136172L07, 136172L08, 141511L22, 37369L10A, 37369L10B, 37837L23A, 37837L23B, 37837L23C, 37837L23D, 51103L05E, 51103L05F, 52748L02A, 52748L02B, 52748L02C, 52748L02D, 52748L02E, 52748L02F, 52748L02G, 52748L02H, 57074L05A, 89910L10

Quantity recalled297 units

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-1412-2017
FDA event ID: 76456
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Terminated
Recall initiated: 9 Feb 2017
FDA classified: 8 Mar 2017
Reported: 15 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Feb 2017	Recall initiated by company
8 Mar 2017	Classified by FDA	+27 days
15 Mar 2017	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

During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

Product as listed by the FDA

Turon Impaction Fixture

Where it was distributed

US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

Questions about this recall

Why was it recalled?

Which lots are affected?

101521L01, 115670L18, 128092L10, 136172L07, 136172L08, 141511L22, 37369L10A, 37369L10B, 37837L23A, 37837L23B, 37837L23C, 37837L23D, 51103L05E, 51103L05F, 52748L02A, 52748L02B, 52748L02C, 52748L02D, 52748L02E, 52748L02F, 52748L02G, 52748L02H, 57074L05A, 89910L10

Where was it sold?

US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

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.

Other products in this recall event

1 other product · FDA event 76456

Reported	Class	Recall	Company	Reason	Where
15 Mar 2017	CLASS II	RSP Impaction Fixture recalled by Encore Medical	Encore Medical	Other	TX

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