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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67711

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

Open FDA event record

Event summary

Timeline bucket
March 11, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

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

7 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 7

Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.

Z-1555-2014
Recall number
Z-1555-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Code information

Product Code 1154654 - Lot 02K0801212

Distribution pattern

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

device · product 2 of 7

Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation.

Z-1556-2014
Recall number
Z-1556-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Code information

Product Code 0100019-507 -Lot 02F1301128, Product Code 6-511 - Lot 02M0800561, Product Code 6-559 - Lot 02A0800005, Product Code 69-403 - Lot 02H0802530, Product Code 7-5008M4 - Lot 02C0900466, Product Code 7-518 - Lot 02E1302561, Product Code 7-565 - Lot 02B1100185, Product Code 7-655A - Lot 02C0901963, Product Code 7-655A - Lot 02M0800836, Product Code 7-740 - Lot 02L1000536, Product Code 833-114 - Lot 02A1202112, 02C0902841, 02C0903374, 02D1202794, 02F0902697, 02K1100404, 02L1202369, 02M0802509, Product Code E13-6351 - Lot 02F0902446, Product Code E13-6354 - Lot 02F0902439, Product Code E13-6399 - Lot 02F0902436, Product Code E6-545 Lot 02F0902443, Product Code E7-4578 Lot 02D0901672, Product Code RN6-5106M5 - Lot 02F1003837, Product Code RN7-536M5 - Lot 02A0801205, Product Code TEV100 - Lot 02G1101500, Product Code V-2599 - Lot 02F0802055, 02F0802055, Product Code X-5424 - Lot 02B0900765, Product Code X6-692W - Lot 02C0803135, Product Code X7-655M6A - Lot 02A0900806, 02A0902742, 02C0900446, 02H1003233, Product Code XF7-7011 - Lot 02A0901594

Distribution pattern

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

device · product 3 of 7

Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.

Z-1557-2014
Recall number
Z-1557-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Code information

Product Code 833-123 - Lot 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, 02K1102309, Product Code 833-124 - Lot 02A1200503, 02B1101450, 02C0903400, 02D0900010, 02D0900103, 02D1003285, 02D1003286 02F1302321, 02G1000045, 02G1300348, 02G1301122, 02H1100494, 02L0803407, 02L1100009, 02M1002289, 02M1101933, 02F1302322, Product Code 833-213 - Lot 02H1100687, Product Code D-5007K - Lot 02B1002310, 02C1103731, 02F1100069, 02H1102294, Product Code D-5007M4A - Lot 02M0902844, Product Code D-5007M4K - Lot 02C1002252, 02F1100124, Product Code D-7016M4K - Lot 02G1301749, Product Code D-7070K - Lot 02A1103450, 02B1002276, Product Code D-7070M4K - Lot 02C1103707, 02F1301100, 02G1100876, 02G1301739, 02F1101036, 02J1301343, 02K0900010, Product Code D-7076M1K - Lot 02H1103237, Product Code D-7375K - Lot 02A1201015, Product Code D-793M4K - Lot 02L1002488, Product Code ED-6072 - Lot 02C1002218, 02E1002342, 02J0902517, Product Code ED-6276 - Lot 02F0902457, Product Code ED-6896 - Lot 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, 02G1301755, Product Code ED-852 - Lot 02G1002594, Product Code ED-863 - Lot 02B0902976, 02D0902457, 02M0901348.

Distribution pattern

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

device · product 4 of 7

Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.

Z-1558-2014
Recall number
Z-1558-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Code information

Product Code BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137

Distribution pattern

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

device · product 5 of 7

Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.

Z-1559-2014
Recall number
Z-1559-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Code information

Product Code H5300 - Lot 1450153E13

Distribution pattern

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

device · product 6 of 7

Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Z-1560-2014
Recall number
Z-1560-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Code information

Product Code X-4981M4 - Lot 02J0800451

Distribution pattern

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

device · product 7 of 7

Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.

Z-1561-2014
Recall number
Z-1561-2014
Initiated
March 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
32,271 ea.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Code information

Product Code X-6371M5 - Lot 02E0801603

Distribution pattern

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

Field note

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