CLASS II Device recall · Reported 10 Jun 2015 · FDA Enforcement Report
PRI Femoral Impactor Block for knee prosthesis surgery recalled
Zimmer is recalling PRI Femoral Impactor Block for knee prosthesis surgery, distributed nationwide in the US. The recall was initiated on 30 Apr 2015 and the FDA has classified it as Class II.
Check your package
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-1696-2015
- FDA event ID
- 71250
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2015
- FDA classified
- 29 May 2015
- Reported
- 10 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 30 Apr 2015 | Recall initiated by company | |
| 29 May 2015 | Classified by FDA | +29 days |
| 10 Jun 2015 | 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
Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
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
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Where it was distributed
Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaIllinoisIndianaKansasMassachusettsMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioOklahomaPennsylvaniaPuerto RicoTennessee
Questions about this recall
Why was it recalled?
Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
Which lots are affected?
Item No. 00-5901-032-00 Lots: 56572845 56574197 56574534 56574775 56575838 56573249 56574198 56574535 56575827 56575839 56573282 56574325 56574536 56575828 56575840 56573283 56574326 56574604 56575829 56576089 56573284 56574327 56574605 56575830 56576090 56573285 56574328 56574606 56575831 56576091 56574130 56574329 56574607 56575832 56576421 56574135 56574530 56574608 56575833 56576429 56574136 56574531 56574617 56575836 56576431 56574137 56574532 56574714 56575837 56576544 56574196 56574533 56574774
Where was it sold?
Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.
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.
More recalls from Zimmer
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|---|---|---|---|---|---|
| Device | CLASS II | Off-Axis Comprehensive Shoulder System, Large, Augment recalled | Zimmer | Foreign Material | Nationwide |
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| Device | CLASS II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
| Device | CLASS II | Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled | Zimmer | Packaging Defects | IN |
| Device | CLASS II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |