PSX PROXIMATE Skin Staple Extractor — Class II medical device recall Z-0918-2013
Terminated recall by Ethicon Endo-Surgery Inc, reported 2013-03-13, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. Damage to the packaging may have compromised the sterility of the device.
| Recall number | Z-0918-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Cincinnati, OH, United States |
| Recall initiated | 2012-10-04 |
| Classified | 2013-03-07 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2013-06-11 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, EC, EG, ES, GB, GR, GT, HK, HU, ID, IL, IN, IT, JM, JO, JP, KR, KW, MX, MY, NI, NL, PA, PE, PH, PK, PL, PT, SA, SG, SI, TH, TR, TT, UY, VE, ZA |
| Quantity | 5,894,975 units |
| Reason classes | sterility |
| Expiration dates | 2012-09-20 |
Product
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Reason for recall
Damage to the packaging may have compromised the sterility of the device.
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-0918-2013. 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.