Device recall: SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft…

Class II FDA enforcement event 63121. Recall start date: 6 Sep 2012. Status in the FDA record: Terminated. Termination date: 3 Jun 2015.

Reason for recall, in the words of FDA

Fracture of SPIRALOK Anchors post op, requiring patient revision

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

DePuy Mitek, Inc., a Johnson & Johnson Co. started this device recall on 6 Sep 2012. The firm address in the FDA record is in Raynham, MA. FDA put the recall in Class II. FDA event 63121 has 16 product records. The first FDA enforcement report date is 31 Oct 2012. The record gives the status Terminated, with the termination date 3 Jun 2015.

FDA enforcement report The 16 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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…

Recalling firm

DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

16 product records in the event.

FDA event 63121: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0140-2013	SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 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	1315 units	Class II	Terminated	31 Oct 2012
Z-0141-2013	SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 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	2560 units	Class II	Terminated	31 Oct 2012
Z-0142-2013	SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 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	314 units	Class II	Terminated	31 Oct 2012
Z-0143-2013	SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 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	372 units	Class II	Terminated	31 Oct 2012
Z-0144-2013	SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 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	400 units	Class II	Terminated	31 Oct 2012
Z-0145-2013	SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 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	232 units	Class II	Terminated	31 Oct 2012
Z-0146-2013	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	94 units	Class II	Terminated	31 Oct 2012
Z-0147-2013	Screw, fixation, boneProduct Number: 222967 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	66 units	Class II	Terminated	31 Oct 2012
Z-0148-2013	SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 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	7 units	Class II	Terminated	31 Oct 2012
Z-0149-2013	SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 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	0	Class II	Terminated	31 Oct 2012
Z-0150-2013	SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 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	7 units	Class II	Terminated	31 Oct 2012
Z-0151-2013	SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 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	0	Class II	Terminated	31 Oct 2012
Z-0152-2013	SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 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	25,393 units	Class II	Terminated	31 Oct 2012
Z-0153-2013	SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 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	39,362 units	Class II	Terminated	31 Oct 2012
Z-0154-2013	SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 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	4,151 units	Class II	Terminated	31 Oct 2012
Z-0155-2013	SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 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	4,321 units	Class II	Terminated	31 Oct 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class II: 88%
Product records in this event: 16Median of the firm: 2
Events of the firm on the register: 16

Other events of the firm

Other FDA enforcement events of DePuy Mitek, Inc., a Johnson & Johnson Co.
Initiated	Product (first record)	Type	Class	Records
24 Feb 2025	COR Disposable Kit, 8 mm. Cartilage Transplant System.	Device	Class II	2
13 Apr 2023	DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate	Device	Class II	5
4 Nov 2019	Healix Knotless ADV BR 4.75 Suture Anchor	Device	Class II	2
30 Aug 2018	Mitek Screw and Washer Depth Gauge, Product Code 219024	Device	Class II	1
22 Dec 2017	LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to	Device	Class II	1
31 Aug 2017	1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irr	Device	Class II	1
12 May 2017	DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set i	Device	Class II	5
23 Nov 2015	VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)	Device	Class II	1
20 Nov 2015	FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving,	Device	Class II	3
29 Aug 2013	DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for F	Device	Class II	2

DePuy Mitek, Inc., a Johnson & Johnson Co.: all 16 events

Official channels

FDA enforcement report Z-0140-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 63121. https://recallregister.com/fda/ii/63121/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: 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…
What quantity of product is in FDA event 63121?: The event has 16 product records. The first record gives this quantity: 1315 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.