CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report

Drill, cannulated, 2.5x95mm, round shaft recalled by Zimmer

Zimmer is recalling Drill, cannulated, 2.5x95mm, round shaft, distributed in 42 states. The recall was initiated on 8 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll items marked with "Normed" are affected

Quantity recalledN/A

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-1438-2019
FDA event ID: 82642
Recalling firm: Zimmer, Winterthur, N/A
Classification: Class II
Status: Terminated
Recall initiated: 8 Apr 2019
FDA classified: 23 May 2019
Reported: 29 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

8 Apr 2019	Recall initiated by company
23 May 2019	Classified by FDA	+45 days
29 May 2019	Published in enforcement report	+6 days

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

Reason for recall

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Product as listed by the FDA

Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620

Where it was distributed

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

Alabama Arkansas Arizona California Colorado Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Which lots are affected?

All items marked with "Normed" are affected

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

75 other products · FDA event 82642

This product is part of a recall event; the main page for the event is V-tek", IVP step drill 2.5-3.9x124mm stop, contra-angle recalled.

Reported	Class	Recall	Company	Reason	Where
29 May 2019	CLASS II	V-tek", IVP step drill 2.5-3.9x124mm stop, contra-angle recalled	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, contra-angle, 1.5x85mm recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 3x90mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS micro, countersink, cannulated, round-shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill stop, 1x83mm, Stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2.5x95mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw, 2.5x120mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2.8x150mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", IVP step drill 2.5-3.9x124mm stop, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 3x90mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS 4.0 countersink, cannulated stop, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2.8x120mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 4x120mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw, 2x120mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill stop, 1.4x94mm, Stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS 7.5 tap, cannulated, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw stop, 2x103mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw, 2.5x120mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill stop, 1.4x94mm, stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", Micro-countersink, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2x95mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS high, countersink, cannulated, round-shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2.8x120mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, 2.5x135mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 4x90mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS 4.5 countersink, cannulated stop, round-shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, 3.2x145mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2x95mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 3.5x90mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2.5x95mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, contra-angle, 1.5x85mm recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 3x90mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS micro, countersink, cannulated, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 3.5x90mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", micro-countersink, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2x95mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill Sys2.7, 2x103mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Osteofresh arthrodesis drill, 2x70mm, center tip, AO stop recalled	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 4x90mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill Sys 2.7, 2x105mm, stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, 2.5x94mm, Stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", standard-countersink, cannulated, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill stop, 1.9x87mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, 2.5x87mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2x95mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill stop, 1x76mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 4x150mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS micro, countersink, cannulated, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 3x90mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill stop, 1.9x94mm, Stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw stop, 2x105mm, Stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw stop, 2x103mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", Micro-countersink, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", standard-countersink, cannulated, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 4x120mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", IVP step drill 2-3.4x124mm stop, contra-angle recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	MaxiCan 4.5 countersink, cannulated, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw, 2x125mm, Stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, 2.7x125mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill stop, 1.4x81mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw stop, 2x105mm, Stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw, 2x100mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS high, countersink, cannulated, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS high, countersink, cannulated, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, 3.2x145mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", IVP step drill 2-3.4x124mm stop, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	V-tek", standard-countersink, cannulated, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw, 2x120mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw, 2x100mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill for screw, 2.5x125mm, stryker recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	CBS 4.0 countersink, cannulated stop, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 2.5x95mm, round shaft recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, 2.7x125mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill stop, 1.4x81mm, AO recalled by Zimmer	Zimmer	Other	42 states
29 May 2019	CLASS II	Drill, cannulated, 4x150mm, AO recalled by Zimmer	Zimmer	Other	42 states

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