Z-1137-2016Class II
Product 39 consists of all product under
Zimmer Manufacturing B.V. / initiated 2016-01-11 / Terminated / root cause: packaging
Zimmer Manufacturing B.V. began a recall of Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME... on . FDA classified it as Class II and gives the reason as "As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1137-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer Manufacturing B.V.
- Product
- Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
- Product code
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Reason for recall
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to [email protected]. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
- Quantity in commerce
- 17
- Distribution
- US Nationwide Distribution
- Product codes and lots
- lot no.: 62065298 62221052 62221052N 62093457 62185967 62268539 62334044 62268539N 61555436 62162471 62221049 62268540 62285362 62268540N 62285362N
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1099-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1100-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1101-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1102-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1103-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1104-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1105-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1106-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1107-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1108-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1109-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1110-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1111-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1112-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1113-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1114-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1115-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1116-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1117-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1118-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1119-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1120-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1121-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1122-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1123-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1124-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1125-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1126-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1127-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1128-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1129-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1130-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1131-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1132-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1133-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1134-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1135-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1136-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1137-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1138-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1139-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1140-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1141-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1142-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1143-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1144-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1145-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1146-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1147-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1148-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1149-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1150-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1151-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1152-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1153-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1154-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1155-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1156-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1157-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1158-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1159-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1160-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1161-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1162-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1163-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1164-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1165-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1166-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1167-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1168-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1169-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1170-2016 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.