- ConMed Linvatec Spectrum II Suture Hook Crescent — Class II medical device recall Z-1624-2013
Terminated recall by Surgical Instrument Service And Savings, Inc., reported 2013-07-10, distributed nationwide. The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point whe
| Recall number | Z-1624-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Surgical Instrument Service And Savings, Inc., Redmond, OR, United States |
| Recall initiated | 2013-05-03 |
| Classified | 2013-07-01 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2013-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 15 |
| Reason classes | sterility, packaging |
| Lot numbers | 122504, 122518, 122590, 122592, 123190, 123263 |
| Model numbers | AR-4065-90W, AR-4065S, AR-4068-25TL, AR-4068-25TR, AR-4068-90, C6386 |
Product
- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm. REF AR-4068-25TR Lot 122518 and Lot 123190. - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504. - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey). REF AR-4065S Lot 122590. -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263. Manual surgical instrument for general use
Reason for recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1624-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.