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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64778

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

Open FDA event record

Event summary

Timeline bucket
March 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra LifeSciences Corporation

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

21 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 21

Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

Z-1282-2013
Recall number
Z-1282-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
15,607 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1125807, 1125802, 1125806, 1125804, 1125808, 1111845, 1125805, 1125803, 1125809, 1125810, 1130069, 1130061, 1130064, 1130065, 1130417, 1130521, 1110850, 1111839, 1111621, 1110274, 1105302, 1110669, 1111618, 1112228, 1110160, 1110670, 1111606, 1111616, 1104916, 1111614, 1111615, 1110273, 1111277, 1111849, 1110667, 1104918, 1110853, 1111619, 1111842, 1110666, 1112109, 1112108, 1104917, 1110854, 1111620, 1110276, 1105301, 1111846, 1112225, 1110851, 1111617, 1105303, 1110852, 1110270, 1105304, 1110246, 1112222, 1112224, 1110245, 1111844, 1111850, 1110668, 1125522, 1125628, 1104879, 1110814, 1111610, 1125525, 1104876, 1110815, 1111607, 1125526

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 2 of 21

Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.

Z-1283-2013
Recall number
Z-1283-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
4, 799 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1125682, 1125681 1125817, 1125983, 1126018 1126019, 1130641 1130642, 1110848, 1110849 1111883, 1111354, 1111884 1111936, 1112151 1110256, 1111355

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 3 of 21

DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

Z-1284-2013
Recall number
Z-1284-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
21,179 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1125523, 1125517 1125522, 1125539 1125524, 1125525 1125526, 1125632 1125630, 1125678 1125679 1125677, 1125683 1125628, 1125813 1125814, 1125815 1125629, 1125520 1125521, 1125979 1126031, 1125980 1125981, 1125982 1126030, 1130243 1130071, 1130503 1130379, 1130381 1130384, 1130507 1130374, 1130380 1130382, 1130421 1130505, 1130424 1130654, 1130422 1130423, 1130428 1130639, 1130413 1130414, 1130383 1130425, 1130504 1130506, 1130426 1130427, 1130970 1130827, 1111606 1104879, 1110814 1111610, 1104876 1110815, 1111607 1110268, 1111360 1112339, 1104405 1104877, 1105455 1112008, 1112110 1112111, 1110845 1111940, 1112149 1104880, 1112148 1110244, 1110265 1110846, 1104878 1111609, 1111941 1104881, 1110812, 1110267, 1111359, 1112340, 1105307, 1111611, 1111939, 1112341, 1110266 1112146, 1112147

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 4 of 21

DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.

Z-1285-2013
Recall number
Z-1285-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
52 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1125963, 1130387 1130386, 1130468

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 5 of 21

NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Z-1286-2013
Recall number
Z-1286-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
954 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1112107 1111938, 1112280, 1112038, 1111971 1112279, 1112104, 1112105 1112297,

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 6 of 21

NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Z-1287-2013
Recall number
Z-1287-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
1,661 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 7 of 21

INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Z-1288-2013
Recall number
Z-1288-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
17, 616 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 8 of 21

Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Z-1289-2013
Recall number
Z-1289-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
24,342 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1104789 1104790, 1110793 1112248, 1110248 1111867

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 9 of 21

Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Z-1290-2013
Recall number
Z-1290-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
14, 525 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1110788, 1112217 1110222, 1111357 1111602, 1105255 1110224, 1110225 1111601, 1110223 1110790, 1111603

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 10 of 21

Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Z-1291-2013
Recall number
Z-1291-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
49,500 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1125130 ,1125686 1125687, 1125688 1126015, 1105298 1110145, 1110674 1111854, 1104502 1104503, 1105309 1105310, 1110249 1111366, 1111367 1111368, 1111370 1112262

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 11 of 21

CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Z-1292-2013
Recall number
Z-1292-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
32,790 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1125684, 1125685 1125689, 1126014 1104963, 1110481 1110791, 1110792 1111363, 1111644 1110673, 1111856

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 12 of 21

CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Z-1293-2013
Recall number
Z-1293-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
155,850 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1104500, 1104623 1105315, 1105316 1105317, 1110234 1110235, 1110236 1110237, 1110238 1110239, 1110240 1110784, 1111151 1111152, 1111153 1111155, 1111156 1111157, 1111646 1105300

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 13 of 21

HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Z-1294-2013
Recall number
Z-1294-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
19,030 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1125414, 1126013 1130645, 1110250 1110251, 1110252 1111365, 1111878

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 14 of 21

HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Z-1295-2013
Recall number
Z-1295-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
42,570 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1104622, 1104962 1110241, 1110242 1110264, 1110783

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 15 of 21

OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Z-1296-2013
Recall number
Z-1296-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
17,110 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1126012, 1105396 1105397, 1105398 1105399, 1111364 1111641

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 16 of 21

Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Z-1297-2013
Recall number
Z-1297-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
31,940 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1110144, 1110243 1110782, 1111645

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 17 of 21

OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Z-1298-2013
Recall number
Z-1298-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
812 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1112066

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 18 of 21

BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Z-1299-2013
Recall number
Z-1299-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
20,032 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1104846, 1105175 1105253, 1110810 1110811, 1111149 1111859, 1104847 1105176, 1105254 1110809, 1111860 1104848, 1110819 1110820, 1111148 1111861

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 19 of 21

Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.

Z-1300-2013
Recall number
Z-1300-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
215 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1125812 1125816 1126021

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 20 of 21

BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Z-1301-2013
Recall number
Z-1301-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
32,446 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1105251, 1105462, 1110805, 1110806, 1111144, 1110480, 1111145, 1111358, 1105392, 1110142, 1110807, 1111146, 1111362, 1111640, 1105252, 1105463, 1110808, 1111147, 1111865, 1110671, 1110672, 1111958, 1105393, 1111959, 1105394, 1110480, 1112022, 1105391

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

device · product 21 of 21

Absorbable Collagen Sponge Provided As Intermediate to Another Company

Z-1302-2013
Recall number
Z-1302-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Quantity
84,460 boxes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
process deviation

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Code information

1130055, 1130057, 1130228, 1130229, 1130388, 1105192, 1110821, 1110822, 1110987, 1111023, 1112020, 1112379, 1104815, 1110841, 1110842, 1110843, 1110953, 1110954, 1111022, 1111821, 1105206, 1110844, 1110903, 1110904, 1110931, 1110932, 1112021, 1104791, 1104961, 1105174, 1105453, 1105454, 1110826, 1110827, 1110969, 1111159, 1111160, 1104710, 1110828, 1111158, 1111764

Distribution pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.