TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY — Class II medical device recall Z-0685-2016
Terminated recall by Abeon Medical Corporation, reported 2016-01-27, distributed nationwide. The firm was notified by some of their customers that some of the sealed pouches contain tears compromising th
| Recall number | Z-0685-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abeon Medical Corporation, Brecksville, OH, United States |
| Recall initiated | 2015-11-25 |
| Classified | 2016-01-21 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2016-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, ES, IT, JP, SE |
| Quantity | 1,035 units |
| Reason classes | sterility |
| Lot numbers | 14121931, 14121932, 14122483, 15010125, 15010126, 15010989, 15013122, 15013123, 15023291, 15024395, 15024396, 15031873, 15032061, 15033742, 15034288, 15034503, 15034509, 15040520, 15041108, 15042675, 15044716, 15050175, 15051473, 15051950, 15053401, 15054441, 15054517, 15062598, 15062599, 15062732, 15064578, 15070461, 15070470, 15070490, 15070515, 15076498, 15080317, 15081541, 15082695, 15090147 and 20 more |
| Model numbers | TLC200, TLC300 |
Product
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Reason for recall
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
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-0685-2016. 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.