Recall Z-0357-2020
TriMed Inc. · initiated September 28, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Codes / lots: Lot numbers 91500604 and 91600017
Reason for recall
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
FDA-determined cause: Nonconforming Material/Component
Action taken
The recalling firm issued letters via email on 9/28/2018 explaining the reason for recall and requesting consignees to identify potentially-affected product and quarantine it until a TriMed representative is able to conduct an inspection.
Details
- Recall number
- Z-0357-2020
- Initiated
- September 28, 2018
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 467 hex drivers
- Distribution
- Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
- Recalling firm
- TriMed Inc., Santa Clarita, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0355-2020 Class II | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label…The epoxy on Apex manufactured epoxy-coated instruments can pop off. | 09/28/2018Open, Classified |
| Z-0356-2020 Class II | TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on…The epoxy on Apex manufactured epoxy-coated instruments can pop off. | 09/28/2018Open, Classified |
| Z-0358-2020 Class II | TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is…The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. | 09/28/2018Open, Classified |
| Z-0359-2020 Class II | TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor…The WHD/WHV impactors can rust over time due to an improper manufacturing process. | 09/28/2018Open, Classified |