CLASS II Device recall · Reported 31 Oct 2012 · FDA Enforcement Report

SpiraLok with Ethibond without needles Product Number recalled

DePuy Mitek, Inc., a Johnson & Johnson is recalling SpiraLok with Ethibond without needles Product Number: 222966 Spiralok Anchors are, distributed nationwide in the US. The recall was initiated on 6 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot codes

Quantity recalled94 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-0146-2013
FDA event ID: 63121
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 Sep 2012
FDA classified: 25 Oct 2012
Reported: 31 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

6 Sep 2012	Recall initiated by company
25 Oct 2012	Classified by FDA	+49 days
31 Oct 2012	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

Fracture of SPIRALOK Anchors post op, requiring patient revision

Product as listed by the FDA

SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow

Where it was distributed

Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.

Nationwide Arkansas California Colorado Delaware Illinois Indiana North Carolina Tennessee

Questions about this recall

Why was it recalled?

Fracture of SPIRALOK Anchors post op, requiring patient revision

Which lots are affected?

All lot codes

Where was it sold?

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

15 other products · FDA event 63121

This product is part of a recall event; the main page for the event is SpiraLok with Ethibond and needles Product Number recalled.

Reported	Class	Recall	Company	Reason	Where
31 Oct 2012	CLASS II	SpiraLok with Ethibond and needles Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok 5.0 w/out Needles with violet recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok with Ethibond without needles Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok 6.5 w/Needles with Orthocord Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok 6.5 w/out Needles with Orthocord Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok 6.5 w/out Needles with violet recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	Screw, fixation, boneProduct Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok with Ethibond and needles Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok with Panacryl and needles Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok 5.0 w/Needles with Orthocord Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok 5.0 w/out Needles with Orthocord Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok with Panacryl and needles Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok 5.0 w/Needles with violet recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok with Panacryl without needles Product Number recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
31 Oct 2012	CLASS II	SpiraLok 6.5 w/Needles with violet recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide

More recalls from DePuy Mitek, Inc., a Johnson & Johnson

All 51

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19 Mar 2025Device	CLASS II	COR Disposable Kit w/ Perpendicularity recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
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14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide

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12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide