FDA Device recall Z-1640-2013

- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010…

FDA Device
Class II
terminated
Published 2013-07-10

On 2013-07-10 the FDA classified a Class II recall of - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010… by Surgical Instrument Service And Savings, citing the seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1640-2013
Classification	Class II
Status	terminated
Initiated	2013-05-03
Published	2013-07-10
Last updated	2026-09-13 11:53 UTC
Company	Surgical Instrument Service And Savings
Distribution	US

Product

- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.

Reason

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Identifiers

code_info	123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1640-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.