CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report
Perma-hand Silk Suture recalled by Ethicon
Ethicon is recalling Perma-hand Silk Suture, distributed nationwide in the US. The recall was initiated on 20 Dec 2024 and the FDA has classified it as Class II.
Check your package
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-1097-2025
- FDA event ID
- 96127
- Recalling firm
- Ethicon, San Lorenzo, PR
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Dec 2024
- FDA classified
- 4 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 20 Dec 2024 | Recall initiated by company | |
| 4 Feb 2025 | Classified by FDA | +46 days |
| 12 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Is Perma-hand Silk Suture recalled?
Yes. Ethicon recalled Perma-hand Silk Suture on 20 Dec 2024. The recall is Class II and its status is Ongoing. Recall number Z-1097-2025.
Why was it recalled?
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Which lots are affected?
REF/UDI-DI-GTIN/Lot(expiration): F2416H/10705031238947/103E7C(8/31/2029); EH7808B/10705031239425/103E7A(8/31/2029); 661H/10705031007703/103GR7(8/31/2029), 103H5A(8/31/2029); 1669H/10705031001879/103GR2(8/31/2029), 103J14(8/31/2029); 644H/10705031089594/103EXA(8/31/2029); EH7827B/10705031239074/103EX9(8/31/2029); F3223BH/10705031240940/103EJH(8/31/2029); EH7797BH/10705031239487/103J2H(8/31/2029); 628H/10705031007000/1033PK(7/31/2029); 699G/10705031008625/102TMJ(7/31/2029); K872H/10705031044586/103DBT(8/31/2029); W723H/10705031202450/103G13(8/31/2029); 623H/10705031006898/10386S(8/31/2029); K833H/10705031044388/103K99(8/31/2029); 6664H/10705031089808/103G1B(8/31/2029); X425H/10705031057296/103H4B(8/31/2029); X872H/10705031058187/103DBT(8/31/2029); EH7491H/10705031096806/103D42(8/31/2029)
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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