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Passer
FDA product code HWQ · Class 1 · Orthopedic
486
Registered devices
906
Adverse events
8
Recalls
9
510(k) clearances
Devices with this code
RiverPass — RIVERPOINT MEDICAL, LLCSmith and Nephew — ProvisionMEDLINE — MEDLINE INDUSTRIES, INC.NanoPass — STRYKER CORPORATIONRiverPass — RIVERPOINT MEDICAL, LLCCaplock — GM DOS REIS INDUSTRIA E COMERCIO LTDAENDOBUTTON — Smith & Nephew, Inc.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Arthrex — ProvisionArthrex — ProvisionACCU-PASS — Smith & Nephew, Inc.APEX — Stryker GmbHStabiliHook Left — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMEDLINE — MEDLINE INDUSTRIES, INC.Arthrex — ProvisionBONE MULCH SUTURE LOOP PASSER — Biomet Orthopedics, LLCgSource — GSOURCE LLC25° Right, Champion®+ Slider with Nitinol Passing Wire — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONArthrex — ProvisionProgressive Medical, Inc. — ProvisionSPEEDPASS DISPOSABLE — Biomet Orthopedics, LLCConmed/Linvatec — ProvisionAdler Instrument Company — Adler, Inc.N/A — Smith & Nephew, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-04-01 | Biomet, Inc. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could becom |
| 2015-12-02 | Biomet, Inc. | There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture |
| 2015-12-02 | Biomet, Inc. | There may be a separation and an insufficient weld between the spring and washer. The weld between the spring and washer may fracture, causing the Mamba Suture |
| 2014-09-26 | Biomet, Inc. | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. |
| 2014-09-26 | Biomet, Inc. | An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. |
| 2014-04-15 | Biomet, Inc. | The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2010-01-28 | Linvatec Corp. dba ConMed Linvatec | This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the conten |
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