CLASS II Device recall · Reported 13 Jan 2016 · FDA Enforcement Report
Provide Protection Cap recalled by Biomet 3i
Biomet 3i is recalling Biomet 3i, Provide Protection Cap, distributed nationwide in the US. The recall was initiated on 21 Sep 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-0591-2016
- FDA event ID
- 72446
- Recalling firm
- Biomet 3i, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2015
- FDA classified
- 5 Jan 2016
- Reported
- 13 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 21 Sep 2015 | Recall initiated by company | |
| 5 Jan 2016 | Classified by FDA | +106 days |
| 13 Jan 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Inadequate biocompatibility testing.
Product as listed by the FDA
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.
Stores named: Walmart
Questions about this recall
Is Provide Protection Cap recalled?
Yes. Biomet 3i recalled Provide Protection Cap on 21 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0591-2016.
Why was it recalled?
Inadequate biocompatibility testing.
Which lots are affected?
Model Number: PPC484, Lot Numbers: 970773, 977566, 987984, 1003033, 1038519, 1038520, 1045556, 1046268, 1054540, 1059416, 1059512, 1065495, 1065497, 1071762, 1071763, 1073161, 1073163, 1108328, 1128077, 1139601, 1141281, 1141282, 1150838, 1153463, 1165800, 1167709, 1171489, 1172858, 1173629, 1179005, 1183068, 1184510. Model Number: PPC485, Lot Numbers: 1071764, 1071765, 1118826, 1143159, 1171487, 1178795, 1179690. Model Number PPC654, Lot Numbers: 977565, 987983, 1004138, 1009002, 1032456, 1033485, 1034852, 1035364, 1053562, 1053563, 1053564, 1053860, 1054512, 1065507, 1069998, 1069999, 1071165 , 1071167, 1088473, 1088475, 1104109, 1104110, 1121837, 1128074, 1128623, 1150839, 1153465, 1161360, 1165775, 1168905, 1168906, 1171488, 1173628, 1175898, 1177389, 1177390, 1181586, 1181587, 1184511, 1185509, 1185511. Model Number PPC655, Lot Numbers: 1032473, 1057790, 1086562, 1088470, 1166995, 1176293.
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.
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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