Z-1112-2016Class II
Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE...
Zimmer Manufacturing B.V. / initiated 2016-01-11 / Terminated / root cause: packaging
Zimmer Manufacturing B.V. began a recall of Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW... 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-1112-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer Manufacturing B.V.
- Product
- Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW 225600235 ASIA ONE-PIECE LAG SCREW 225600237 ASIA ONE-PIECE LAG SCREW 225600240 ASIA ONE-PIECE LAG SCREW 225600242 ASIA ONE-PIECE LAG SCREW 225600245 ASIA ONE-PIECE LAG SCREW 225600227 ASIA ONE-PIECE LAG SCREW 70MM Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
- Product code
- HSB Rod, Fixation, Intramedullary And Accessories
- 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
- 0
- Distribution
- US Nationwide Distribution
- Product codes and lots
- lot no.: 61902234 61930449 62238240 61781914 61818112 61873640 61873641 61921821 61930453 62142331 62171289 61656184 61656185 61663560 61818114 61818116 61818118 61873642 61930459 61969224 61969225 62118686 62238244 62250669 62279154 62279156 61640868 61781919 61781920 61866144 61866145 61969228 62122251 62142308 62171295 62255624 62279159 61663622 61781922 61781927 61831643 61862302 61930474 62142311 62232636 62238251 62283223 62283223N 61663623 61781928 61866147 62092290 62155425 62031720
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.