CLASS II Device recall · Reported 7 Oct 2020 · FDA Enforcement Report

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit mm recalled

Exactech is recalling Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit mm, distributed nationwide in the US. The recall was initiated on 24 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 320-20-22 Serial Numbers: S071601, S071602, S071603, S071604, S071605, S071606, S071607, S071608, S071609, S071610, S071611, S071612, S071613, S071614, S071616, S071617, S071618, S071619, S071620, S071621, S071622, S071623, S071624, S071625, S071626, S071627, S071628, S071629, S071630, S071631, S071632, S071633, S071634, S071635, S071636, S071637, S071638, S071639, S071640, S071641, S071642, S071643, S071644, s071645, S071646, S071647, S071648, S071649, S071650, S071651, S071652, S071653, S071654, S071655, S071656, S071657, S071658, S071659, S071660, S071661, S071662, S071663, S071664, S071665, S071666, S071668, S071669, S071670, S071671, S071672, S071673, S071674, S071675, S071676, S071678, S071679, S071680, S071681, S071682, S071683, S071684, S071685, S071686, S071687, S071688, S071689, S071690, S071691, S071692, S071693, S071694, S071695, S071696, S071697, S071698, S071700, S071701, S071702, S071703, S071704, S071705, S071706, S071707, S071708, S071709, S071710, S071711, S071712, S071713, S071714, S071715, S071716, S071717, S071718, S071719, S071720, S071721, S071724, S071725, S071726, S071727, S071728, S071729, S071730, S071731, S071732, S071733, S071734, S071735, S071736, S071737, S071738, S071739, S071740, S071741, S071742, S071743, S071744, S071745, S071747, S071748, S071749, S071750, S071751, S071752, S071753, S071754, S071755, S071756, S071757, S071758, S071759, S071760, S071761, S071762, S071763, S071765, S071766, S071767, S071768, S071769, S071770, S071771, S071772, S071773, S071774, S071775, S071776, S071777, S071778, S071781, S071782, S071783, S071784, S071785, S071786, S071787, S071788, S071789, S071790, S071791, S071792, S071793, S071794, S071795, S071796, S071797, S071798, S071799, S071800.

Quantity recalled149 devices

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-3020-2020
FDA event ID: 86396
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 24 Aug 2020
FDA classified: 25 Sep 2020
Reported: 7 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Aug 2020	Recall initiated by company
25 Sep 2020	Classified by FDA	+32 days
7 Oct 2020	Published in enforcement report	+12 days

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

Reason for recall

Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.

Product as listed by the FDA

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

Where it was distributed

Domestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa.

Nationwide Arkansas Arizona California Colorado Florida Georgia Hawaii Idaho Illinois Indiana Kansas Kentucky Louisiana Maine Minnesota New York Ohio South Carolina Tennessee Texas

Questions about this recall

Is Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit mm recalled?

Yes. Exactech recalled Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit mm on 24 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-3020-2020.

Why was it recalled?

Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.

Which lots are affected?

Catalog Number: 320-20-22 Serial Numbers: S071601, S071602, S071603, S071604, S071605, S071606, S071607, S071608, S071609, S071610, S071611, S071612, S071613, S071614, S071616, S071617, S071618, S071619, S071620, S071621, S071622, S071623, S071624, S071625, S071626, S071627, S071628, S071629, S071630, S071631, S071632, S071633, S071634, S071635, S071636, S071637, S071638, S071639, S071640, S071641, S071642, S071643, S071644, s071645, S071646, S071647, S071648, S071649, S071650, S071651, S071652, S071653, S071654, S071655, S071656, S071657, S071658, S071659, S071660, S071661, S071662, S071663, S071664, S071665, S071666, S071668, S071669, S071670, S071671, S071672, S071673, S071674, S071675, S071676, S071678, S071679, S071680, S071681, S071682, S071683, S071684, S071685, S071686, S071687, S071688, S071689, S071690, S071691, S071692, S071693, S071694, S071695, S071696, S071697, S071698, S071700, S071701, S071702, S071703, S071704, S071705, S071706, S071707, S071708, S071709, S071710, S071711, S071712, S071713, S071714, S071715, S071716, S071717, S071718, S071719, S071720, S071721, S071724, S071725, S071726, S071727, S071728, S071729, S071730, S071731, S071732, S071733, S071734, S071735, S071736, S071737, S071738, S071739, S071740, S071741, S071742, S071743, S071744, S071745, S071747, S071748, S071749, S071750, S071751, S071752, S071753, S071754, S071755, S071756, S071757, S071758, S071759, S071760, S071761, S071762, S071763, S071765, S071766, S071767, S071768, S071769, S071770, S071771, S071772, S071773, S071774, S071775, S071776, S071777, S071778, S071781, S071782, S071783, S071784, S071785, S071786, S071787, S071788, S071789, S071790, S071791, S071792, S071793, S071794, S071795, S071796, S071797, S071798, S071799, S071800.

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 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.

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