CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Restoris PST Acetabular Straight Shell Impactors recalled

Mako Surgical is recalling Restoris PST Acetabular Straight Shell Impactors An impactor is a reusable instrument, distributed nationwide in the US. The recall was initiated on 7 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 207390, Lot Numbers: 21948201, 21948302, 21948403, 21948501, 21948605 and 21948704.

Quantity recalledTotal 404

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-0829-2015
FDA event ID: 69465
Recalling firm: Mako Surgical, Plantation, FL
Classification: Class II
Status: Terminated
Recall initiated: 7 Oct 2014
FDA classified: 18 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

7 Oct 2014	Recall initiated by company
18 Dec 2014	Classified by FDA	+72 days
24 Dec 2014	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

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

Product as listed by the FDA

RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

Where it was distributed

Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.

Nationwide Arizona California Colorado Connecticut Florida Georgia Idaho Illinois Indiana Louisiana Massachusetts Michigan North Carolina New Hampshire New Jersey New York Ohio Oklahoma Pennsylvania Rhode Island

Questions about this recall

Is Restoris PST Acetabular Straight Shell Impactors An impactor is a reusable instrument recalled?

Yes. Mako Surgical recalled Restoris PST Acetabular Straight Shell Impactors An impactor is a reusable instrument on 7 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0829-2015.

Why was it recalled?

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

Which lots are affected?

Part Number: 207390, Lot Numbers: 21948201, 21948302, 21948403, 21948501, 21948605 and 21948704.

Where was it sold?

Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.

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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