CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report

Cannulated Drill Bit for Mini TightRope recalled

Surgical Instrument Service And Savings is recalling Cannulated Drill Bit for Mini TightRope, distributed nationwide in the US. The recall was initiated on 3 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes122347, 122289, 122322, 122511.

Quantity recalled10

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-1635-2013
FDA event ID: 65205
Recalling firm: Surgical Instrument Service And Savings, Redmond, OR
Classification: Class II
Status: Terminated
Recall initiated: 3 May 2013
FDA classified: 1 Jul 2013
Reported: 10 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

3 May 2013	Recall initiated by company
1 Jul 2013	Classified by FDA	+59 days
10 Jul 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Cannulated Drill Bit for Mini TightRope recalled?

Yes. Surgical Instrument Service And Savings recalled Cannulated Drill Bit for Mini TightRope on 3 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1635-2013.

Why was it recalled?

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

Which lots are affected?

122347, 122289, 122322, 122511.

Where was it sold?

Nationwide Distribution.

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 21 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 Surgical Instrument Service And Savings

All 22

Reported	Class	Recall	Company	Reason	Where
10 Jul 2013Device	CLASS II	Average Medium Blade recalled by Surgical Instrument Service	Surgical Instrument Service And Savings	Foreign Material	Nationwide
10 Jul 2013Device	CLASS II	GII QuickAnchor Plus, Ethibond Polyester Suture, 36" recalled	Surgical Instrument Service And Savings	Foreign Material	Nationwide
10 Jul 2013Device	CLASS II	Harmonic ACE Ergonomically-Enhanced Curved Shear recalled	Surgical Instrument Service And Savings	Sterility	Nationwide
10 Jul 2013Device	CLASS II	ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) recalled	Surgical Instrument Service And Savings	Sterility	Nationwide
10 Jul 2013Device	CLASS II	Large Tear Cross Cut Rasp recalled by Surgical Instrument Service	Surgical Instrument Service And Savings	Sterility	Nationwide

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