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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63121

16 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 06, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Mitek, Inc., a Johnson & Johnson Co.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

16 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 16

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

Z-0140-2013
Recall number
Z-0140-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
1315 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 2 of 16

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

Z-0141-2013
Recall number
Z-0141-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
2560 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 3 of 16

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

Z-0142-2013
Recall number
Z-0142-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
314 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 4 of 16

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

Z-0143-2013
Recall number
Z-0143-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
372 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 5 of 16

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

Z-0144-2013
Recall number
Z-0144-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 6 of 16

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

Z-0145-2013
Recall number
Z-0145-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
232 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 7 of 16

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

Z-0146-2013
Recall number
Z-0146-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
94 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 8 of 16

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

Z-0147-2013
Recall number
Z-0147-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
66 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 9 of 16

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

Z-0148-2013
Recall number
Z-0148-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 10 of 16

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

Z-0149-2013
Recall number
Z-0149-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 11 of 16

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

Z-0150-2013
Recall number
Z-0150-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 12 of 16

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

Z-0151-2013
Recall number
Z-0151-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 13 of 16

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

Z-0152-2013
Recall number
Z-0152-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
25,393 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 14 of 16

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

Z-0153-2013
Recall number
Z-0153-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
39,362 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 15 of 16

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

Z-0154-2013
Recall number
Z-0154-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
4,151 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.

device · product 16 of 16

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

Z-0155-2013
Recall number
Z-0155-2013
Initiated
September 06, 2012
Classification
Class II
Status
Terminated
Quantity
4,321 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture of SPIRALOK Anchors post op, requiring patient revision

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture of SPIRALOK Anchors post op, requiring patient revision

Code information

All lot codes

Distribution pattern

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.