CLASS II Device recall · Reported 29 Jun 2016 · FDA Enforcement Report
Sharpoint Polypropylene Blue Monofilament 6" recalled
SSC- Surgical Specialties is recalling Sharpoint Polypropylene Blue Monofilament 6"/ 9-0 USP, Product No. J2558N, distributed in 9 states. The recall was initiated on 20 May 2016 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-2042-2016
- FDA event ID
- 74230
- Recalling firm
- SSC- Surgical Specialties, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 May 2016
- FDA classified
- 21 Jun 2016
- Reported
- 29 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 May 2016 | Recall initiated by company | |
| 21 Jun 2016 | Classified by FDA | +32 days |
| 29 Jun 2016 | 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
Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
Product as listed by the FDA
Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
Where it was distributed
TX, ME, MA, MI, OH, KS, MN, KS, TN, GA
GeorgiaKansasMassachusettsMaineMichiganMinnesotaOhioTennesseeTexas
Questions about this recall
Why was it recalled?
Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
Which lots are affected?
MAPX540
Where was it sold?
TX, ME, MA, MI, OH, KS, MN, KS, TN, GA
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SSC- Surgical Specialties
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sharpoint, Angled, Double- Bevel recalled by SSC- Surgical Specialties | SSC- Surgical Specialties | Packaging Defects | Nationwide |
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